tag:www.gov.uk,2005:/government/announcementsAnnouncements on GOV.UKHM Government2018-02-21T15:55:00+00:00tag:www.gov.uk,2005:AnnouncementPresenter/3784552018-02-21T15:55:00+00:002018-02-21T15:55:00+00:00News story: Batches of Ventolin Accuhaler and Seretide Accuhaler asthma inhalers recalledThree specific lots of asthma inhalers are being recalled, including preventer and emergency relief inhalers.<div class="govspeak"><p>People with asthma are being asked to replace specific batches of their Ventolin Accuhaler inhalers, used for the emergency relief of asthmatic symptoms. This is due to a manufacturing issue that results in a small number of the devices not delivering the full number of doses.</p>
<p>The Medicines and Healthcare products Regulatory Agency (MHRA) has today issued a patient level drug alert recalling two specific affected lots manufactured by Glaxo Wellcome UK Limited.</p>
<p>Patients who have used the affected batches of Ventolin may find that their symptoms are not relieved as normal by their Ventolin Accuhaler. If this happens, they should seek medical advice. Affected Accuhalers should be returned to their pharmacist for a replacement.</p>
<p>Additionally, one lot of Seretide Accuhaler, used for the maintenance of preventative treatment of asthma, is being recalled from hospitals, pharmacies, dispensing practices, retailers and wholesalers in the UK.</p>
<p>The recall of Seretide Accuhaler is pharmacy level because this is used for maintenance treatment as opposed to a reliever treatment.</p>
<p>The two affected batches of Ventolin Accuhaler and the one affected batch of Seretide were distributed to the UK market.</p>
<p>Only a small proportion of the units are defective (images below). Other asthma inhalers, including the more commonly used Ventolin Evohaler, are not affected.</p>
<p>Bernadette Sinclair Jenkins, MHRA’s Regulatory Assessment Unit Manager of the Inspections, Enforcement and Standards unit said:</p>
<blockquote>
<p>It is important people check whether they have an affected inhaler. We want patients and their families to be confident treatment will be safe and effective when required.”</p>
<p>People with a Ventolin Accuhaler from the affected lots should take them to their pharmacy or their
dispensing practice and speak to a pharmacist who will provide a replacement.</p>
<p>We strongly encourage anyone to report any issues with their inhalers or other medicines or medical devices to MHRA via our Yellow Card Scheme.</p>
<p class="last-child">Information is also available to patients and healthcare professionals by contacting GSK’s Customer Support Team via <a href="mailto:customercontactuk@gsk.com">customercontactuk@gsk.com</a> or calling on 0800 221 441 (option 4).</p>
</blockquote>
<table>
<thead>
<tr>
<th>Product Description</th>
<th>Lot details</th>
<th>Final market</th>
<th>Expiry Date</th>
</tr>
</thead>
<tbody>
<tr>
<td>Ventolin 200mcg – Accuhaler 1x60D</td>
<td>786G</td>
<td>UK</td>
<td>05/2019</td>
</tr>
<tr>
<td>Ventolin 200mcg – Accuhaler 1x60D</td>
<td>754P</td>
<td>UK</td>
<td>05/2019</td>
</tr>
<tr>
<td>Seretide 50/250mcg - Accuhaler 1x60D</td>
<td>5K8W</td>
<td>UK</td>
<td>04/2019</td>
</tr>
</tbody>
</table>
<figure class="image embedded"><div class="img"><img src="https://assets.publishing.service.gov.uk/government/uploads/system/uploads/image_data/file/71980/Accuhaler-754P-lot-back_3.jpg" alt="Accuhaler-754P-lot-back "></div>
<figcaption>Two batches of Ventolin Accuhaler are being recalled</figcaption></figure>
<figure class="image embedded"><div class="img"><img src="https://assets.publishing.service.gov.uk/government/uploads/system/uploads/image_data/file/71981/Accuhaler-5K8W-lot-front-Seretide_2.jpg" alt="Accuhaler-5K8W-lot-front-Seretide "></div>
<figcaption>One lot of Seretide is being recalled from hospitals, pharmacies, dispensing practices, retailers and wholesalers in the UK</figcaption></figure>
<figure class="image embedded"><div class="img"><img src="https://assets.publishing.service.gov.uk/government/uploads/system/uploads/image_data/file/71982/Accuhaler-5K8W-lot-back_1.jpg" alt="Accuhaler-5K8W-lot-back-Seretide "></div>
<figcaption>One lot of Seretide is being recalled from hospitals, pharmacies, dispensing practices, retailers and wholesalers in the UK</figcaption></figure>
<h3 id="notes-to-editor">Notes to Editor</h3>
<ol>
<li>
<p>MHRA is responsible for regulating all medicines and medical devices in the UK. All our work is underpinned by robust and fact-based judgments to ensure that the benefits justify any risks. MHRA is a centre of the Medicines and Healthcare products Regulatory Agency which also includes the <a rel="external" href="http://www.nibsc.org/">National Institute for Biological Standards and Control (NIBSC)</a> and the <a rel="external" href="https://www.cprd.com/intro.asp">Clinical Practice Research Datalink (CPRD)</a>. The Agency is an executive agency of the Department of Health. <a rel="external" href="http://www.mhra.gov.uk">www.mhra.gov.uk</a></p>
</li>
<li>
<p><a href="https://www.gov.uk/drug-device-alerts/class-2-medicines-recall-seretide-accuhaler-50-microgram-250-microgram-dose-inhalation-powder-pre-dispensed">Link to Seretide alert</a></p>
</li>
<li>
<p><a href="https://www.gov.uk/drug-device-alerts/class-2-medicines-recall-ventolin-accuhaler-200mcg-salbutamol-sulfate">Link to Ventolin alert</a></p>
</li>
<li>
<p><a rel="external" href="https://yellowcard.mhra.gov.uk/">Link to Yellow Card Scheme</a></p>
</li>
</ol>
</div>tag:www.gov.uk,2005:AnnouncementPresenter/3781412018-02-16T10:30:00+00:002018-02-16T10:30:00+00:00News story: Esmya: no new treatment courses prescribed until further noticeTemporary safety measures have been introduced whilst the EMA review is ongoing following a further case of serious liver injury requiring liver transplant.<div class="govspeak"><p>In December 2017, the European Medicines Agency started a review of Esmya (Ulipristal acetate) for uterine fibroids after it was reported that four cases of serious liver injury had occurred after its use. In three of the cases a liver transplant was needed.</p>
<p>As of February 2018, temporary safety measures have been introduced whilst the review is ongoing following a further case of serious liver injury requiring liver transplant.</p>
<p>The advice is that no new treatment courses should be prescribed until further notice. Those who are already taking Esmya or have recently stopped, it is advisable that they have blood tests to monitor their liver function at least once a month whilst taking the medicine. Treatment with Esmya will be stopped if these blood tests show signs of a possible problem.</p>
<p>If women experience symptoms associated with liver problems (nausea, vomiting, feeling ill, lack of appetite, weakness, upper abdominal pain, yellowing of the skin/eyes) then they must stop treatment and seek medical attention immediately.</p>
<p>Esmya is used to treat moderate to severe uterine fibroids in adult women who have not yet reached the menopause. It is normally taken for up to three months but the course can be repeated.</p>
<p>It’s important to note that there are no concerns for individuals who have taken the emergency contraception ellaOne which also contains Ulipristal acetate. EllaOne is a single use medicine and as no cases of serious liver injury have been reported with its use to date there are currently no similar concerns with this medicine.</p>
<p><a rel="external" href="http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/referrals/Esmya/human_referral_prac_000070.jsp&amp;mid=WC0b01ac05805c516f">Further information about the EMA Review.</a></p>
</div>tag:www.gov.uk,2005:AnnouncementPresenter/3767412018-01-30T11:11:00+00:002018-01-30T11:11:00+00:00News story: Improving collaboration to protect public health – MHRA and Health Inspectorate Wales sign MoUThe Medicines and Healthcare products Regulatory Agency (MHRA) and Health Inspectorate Wales (HIW) set out key principles to support their collaboration on improving public health. <div class="govspeak"><p>Today we have set out how we will work more effectively with HIW in a new <span id="attachment_2517953" class="attachment-inline">
<a href="/government/uploads/system/uploads/attachment_data/file/677828/HIW_MOU_MoU_final.pdf">Memorandum of Understanding (MoU).</a>
(<span class="type"><abbr title="Portable Document Format">PDF</abbr></span>, <span class="file-size">303KB</span>, <span class="page-length">12 pages</span>)
</span></p>
<p>HIW is the independent inspectorate and regulator of healthcare in Wales. They also monitor the use of the Mental Health Act 1983 and 2007, and the Mental Health (Wales) Measure 2010, and protect the interests of people whose rights are restricted under this legislation.</p>
<p>Our working relationship helps maintain an effective regulatory system for health and care in Wales, while promoting patient safety and high quality care.</p>
<p>The new MoU sets out the framework to support our joint working relationship. We agree on how to share information, to carry out regulatory functions and to benefit the public.</p>
<p>The principles of the MoU will:</p>
<ul>
<li>address overlaps and gaps in the regulatory framework and responsibilities</li>
<li>promote open and transparent cooperation</li>
<li>respect each other’s independent status</li>
<li>promote the use of resources and intelligence effectively and efficiently</li>
</ul>
<h3 id="notes-to-editor">Notes to Editor</h3>
<ol>
<li>The Memorandum of Understanding was signed by Dr Kate Chamberlain, Chief Executive, HIW and Dr Ian Hudson, Chief Executive, MHRA.</li>
<li>MHRA is responsible for regulating all medicines and medical devices in the UK. All our work is underpinned by robust and fact-based judgments to ensure that the benefits justify any risks. MHRA is a centre of the Medicines and Healthcare products Regulatory Agency which also includes the <a rel="external" href="http://www.nibsc.org/">National Institute for Biological Standards and Control (NIBSC)</a> and the <a rel="external" href="https://www.cprd.com/intro.asp">Clinical Practice Research Datalink (CPRD)</a>. The Agency is an executive agency of the Department of Health. <a href="https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency">www.mhra.gov.uk</a>
</li>
</ol>
<div class="contact postal-address" id="contact_2345">
<div class="content">
<h3>Media enquiries</h3>
<div class="vcard contact-inner">
<p class="adr">
<span class="fn">News centre</span><br>
<span class="street-address">MHRA
<br>
151 Buckingham Palace Road
<br>
Victoria</span><br>
<span class="locality">London</span><br>
<span class="postal-code">SW1W 9SZ</span>
</p>
<div class="email-url-number">
<p class="email">
<span class="type">Email</span>
<a class="email" href="mailto:newscentre@mhra.gov.uk">newscentre@mhra.gov.uk</a>
</p>
<p class="tel">
<span class="type">During office hours:</span>
020 3080 7651 (08:30 - 17:00)
</p>
<p class="tel">
<span class="type">Out of office hours:</span>
07770 446 189 (17:00 - 08:30)
</p>
</div>
<p class="comments">Office hours are Monday to Friday, 8:30am to 5pm. For real-time updates including the latest press releases and news statements, see our Twitter channel at <a href="https://www.twitter.com/mhrapress">https://www.twitter.com/mhrapress</a></p>
</div>
</div>
</div>
</div>tag:www.gov.uk,2005:AnnouncementPresenter/3758632018-01-17T11:21:32+00:002018-01-17T11:21:32+00:00News story: Parents and carers advised to inspect Buccolam oral syringes before useThe European Medicines Agency (EMA) has reiterated safety messages on Buccolam oral syringes for parents and caregivers.<div class="govspeak"><p>In an alert issued last year, healthcare professionals were asked to speak to parents and carers about carefully inspecting Buccolam pre-filled plastic syringes before giving the medicine.</p>
<p>Buccolam is an epilepsy medicine, which is available as pre-filled oral syringes. A defect with some syringes has been reported. In a small number of cases, the translucent (white) tip-cap can sometimes remain attached to the syringe after the red cap has been taken off, this is a choking hazard.</p>
<p>Buccolam remains safe to use if the patient/carer instructions are followed. Carefully check the syringe before giving the medicine and remove the translucent tip-cap manually if it is still on the syringe after the red cap has been pulled off. A diagram explaining this can be found in the <a href="https://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-buccolam-midazolam-oromuscosal-solution-pre-filled-syringes">alert</a>.</p>
<p>If you think the tip-cap is in the patient’s mouth, do not attempt to remove it. Instead, turn the patient onto their side (recovery position) and make sure they spit it out when they stop fitting.</p>
<p>This is not a new issue, MHRA previously issued <a href="https://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-buccolam-midazolam-oromuscosal-solution-pre-filled-syringes">this alert</a> in December 2017. However, we are now aware of a few rare reports in Europe of a child breathing in or swallowing the tip-cap and the EMA have added guidance on their website.</p>
<p>We want to make sure parents and carers of children who are using Buccolam are aware of the practical steps to take should they need to dispense this medicine. Pharmacists who prescribe and dispense Buccolam have also been asked to share this information with parents and caregivers.</p>
<p>The manufacturer is working to resolve this issue for new syringes.</p>
<p>If patients, parents, or carers have any questions or want to report any side effects, they should talk to a doctor, pharmacist, or nurse. They should also tell them about any occasions in which the translucent tip-cap remained attached to the syringe.</p>
<p>Suspected side effects can also be reported directly to MHRA via the <a rel="external" href="https://yellowcard.mhra.gov.uk/">Yellow Card Scheme</a>.</p>
<div class="contact postal-address" id="contact_2345">
<div class="content">
<h3>Media enquiries</h3>
<div class="vcard contact-inner">
<p class="adr">
<span class="fn">News centre</span><br>
<span class="street-address">MHRA
<br>
151 Buckingham Palace Road
<br>
Victoria</span><br>
<span class="locality">London</span><br>
<span class="postal-code">SW1W 9SZ</span>
</p>
<div class="email-url-number">
<p class="email">
<span class="type">Email</span>
<a class="email" href="mailto:newscentre@mhra.gov.uk">newscentre@mhra.gov.uk</a>
</p>
<p class="tel">
<span class="type">During office hours:</span>
020 3080 7651 (08:30 - 17:00)
</p>
<p class="tel">
<span class="type">Out of office hours:</span>
07770 446 189 (17:00 - 08:30)
</p>
</div>
<p class="comments">Office hours are Monday to Friday, 8:30am to 5pm. For real-time updates including the latest press releases and news statements, see our Twitter channel at <a href="https://www.twitter.com/mhrapress">https://www.twitter.com/mhrapress</a></p>
</div>
</div>
</div>
</div>tag:www.gov.uk,2005:AnnouncementPresenter/3321622016-06-27T12:30:00+01:002018-01-16T11:15:26+00:00News story: Making a success of BrexitThe Agency's response to the outcome of the EU referendum.<p><em>Updated:</em> Updated to include a link to the MHRA update to pharmaceutical companies on exit preparations.</p><div class="govspeak"><p>Following the outcome of the EU referendum, the Medicines and Healthcare products Regulatory Agency (MHRA) is working closely with the Government to analyse the best options and opportunities available for the safe and effective regulation of medicines and medical devices in the UK.</p>
<p>While negotiations continue, the UK remains a full and active member of the EU, with all the rights and obligations of EU membership firmly in place. Working with our partners, stakeholders and customers, our focus remains: protecting health and improving lives.</p>
<div class="call-to-action">
<p><a href="https://www.gov.uk/government/news/mhra-update-to-pharmaceutical-companies-on-exit-preparations">Update on negotiations and further guidance for pharmaceutical companies planning in advance of the final negotiated settlement</a></p>
</div>
<h2 id="medicines-regulation">Medicines regulation</h2>
<p>Playing a full, active role in European regulatory procedures for medicines remains a priority. We contribute significantly in both the centralised and decentralised regulatory procedures, including new rapporteur and reference member state (RMS) appointments, and maintain our programmes for implementing EU legislation as required by our obligations as a Member State. We are also fully engaged in European and national scientific advice services and in delivering our EU inspection-related duties.</p>
<h2 id="devices-regulation">Devices regulation</h2>
<p>Our role in regulating medical devices and in vitro diagnostic (IVD) devices remains integral. We oversee the essential work of the five UK Notified Bodies; together they are responsible for assessing the majority of devices currently placed on the EU market. Our preparations to implement proposed new Regulations for Medical Devices and IVDs continue.</p>
<h2 id="vigilance-and-market-surveillance">Vigilance and market surveillance</h2>
<p>We maintain our role in vigilance, market surveillance and taking direct action, where needed, to protect patients and public health, and we continue to co-ordinate with other Competent Authorities, across Europe and internationally, in these and other areas.</p>
<div class="call-to-action">
<p>Statements are also available from the <a rel="external" href="https://www.pharmacopoeia.com/news/208">British Pharmacopoeia</a> and the <a rel="external" href="http://www.nibsc.org/about_us/latest_news/referendum_statement.aspx">National Institute for Biological Standards and Controls (NIBSC)</a></p>
</div>
<h2 id="future-regulatory-partnership">Future regulatory partnership</h2>
<p>On 4 July the UK Government gave a clear, public statement of its desire to retain a close working partnership in respect of medicines regulation after the UK leaves the EU, in the interests of public health and safety. The statement, published in the Financial Times, by the Secretary of State for Health and Secretary of State for Business, Energy and Industrial Strategy laid out the three principles which will underpin the development of a post-Brexit regulatory system for medicines and devices: patients should not be disadvantaged; innovators should be able to access the UK market as quickly and simply as possible; and we will continue to play a leading role in both Europe and the world in promoting public health.</p>
<p>These principles and the government’s position were developed further in a <a href="https://www.gov.uk/government/speeches/speech-given-by-lord-oshaughnessy-on-brexit-and-medicines-regulation">speech by the Parliamentary Under Secretary of State at the Department of Health, Lord O’Shaughnessy</a>, at the BIA/MHRA conference in London on 14 July.</p>
<p>The commitment to continuing the close working relationship with our European partners with respect of medicines regulation and protecting public health globally is also reiterated on page 14 of the <a href="https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/642542/Science_and_innovation_paper.pdf">Governments Collaboration on science and innovation ‘A Future Partnership Paper’</a> published in September 2017.</p>
<p>More broadly, as part of the <a rel="external" href="http://www.consilium.europa.eu/en/press/press-releases/2017/12/15/european-council-art-50-guidelines-for-brexit-negotiations/">guidelines</a> adopted for the second phase of the negotiations at the European Council meeting on December 15, the European Council reconfirmed it’s desire to establish a close partnership between the UK and EU.</p>
<h2 id="emaeu--cmdh-notices-to-marketing-authorisation-holders">EMA/EU &amp; CMDh notices to Marketing Authorisation Holders</h2>
<p>We are aware of the recent notices to Marketing Authorisation Holders issued by the EMA/EU-27 and CMDh advising of preparations MA holders may want to consider ahead of the UK’s exit from the EU.</p>
<p>Until the exit negotiations are concluded, the UK remains a full member of the EU and all the rights and obligations of EU membership remain in force. We therefore continue to play a full role in the network and to undertake our work as a Reference Member State (RMS) in the decentralised procedure, and as (co-) rapporteur in the centralised procedure. If, however you do want to consider preparation for any potential changes to marketing authorisation or RMS, please see the information provided by the <a rel="external" href="http://www.ema.europa.eu">EMA</a> and the <a rel="external" href="http://www.hma.eu/">HMA</a>.</p>
<p>Whatever the outcome of the negotiation we will continue to collaborate with all involved to deliver the current speed of authorisations, access to new and innovative medicines and devices and to continue to ensure the quality, safety and efficacy of all medicines and devices, to safeguard an uninterrupted level of public health protection.</p>
<div class="call-to-action">
<p>Customers, partners and stakeholders approaching MHRA continue to have access to our internationally recognised expertise and we maintain the highest quality services. For further information, please get in touch with your usual contact points in the Agency.</p>
</div>
</div>tag:www.gov.uk,2005:AnnouncementPresenter/3757722018-01-16T11:11:56+00:002018-01-16T11:11:56+00:00News story: MHRA update to pharmaceutical companies on exit preparationsAn update from the Medicines and Healthcare products Regulatory Agency (MHRA) to pharmaceutical companies on preparations for exiting the European Union<div class="govspeak"><h3 id="update-on-negotiations">Update on negotiations</h3>
<p>The European Council formally agreed on 15 December that sufficient progress has been made to move on to the second stage of the negotiations, and adopted <a rel="external" href="http://www.consilium.europa.eu/en/press/press-releases/2017/12/15/european-council-art-50-guidelines-for-brexit-negotiations/">guidelines</a> for that second phase.</p>
<p>This followed the publication of a <a href="https://www.gov.uk/government/publications/joint-report-on-progress-during-phase-1-of-negotiations-under-article-50-teu-on-the-uks-orderly-withdrawal-from-the-eu">Joint Report on progress during the first phase</a> by the Government and the European Commission on 8 December.</p>
<p>These are important steps forward for both sides and demonstrate the shared interest in managing our exit smoothly, and in moving on with our negotiations.</p>
<p>In the context of ensuring continuity in the availability of goods placed on the market under Union law before withdrawal, the Joint Report makes clear that “goods placed on the market under Union law before the withdrawal date may freely circulate on the markets of the UK and the Union with no need for product modifications or re-labelling; be put into service where provided in Union law, and that the goods concerned should be subject to continued oversight.”</p>
<p>The guidelines set out the need for the EU and the UK to complete work on all withdrawal issues and to start drafting the Withdrawal Agreement. The UK looks forward to continuing these discussions.</p>
<p>The EU guidelines also acknowledge the proposal put forward by the UK for a time-limited implementation period, based on the existing structure of EU rules and regulations. The aim is for access to one another’s markets to continue on current terms throughout this period, and for it to be based on the existing structure of EU rules and regulations.</p>
<p>Both parties have recognised the importance of such a period in the interests of providing certainty and continuity to businesses and individuals, and the EU is expected to adopt additional negotiating directives on transitional arrangements in January 2018. The UK expects to be able to rapidly agree the detail with the EU in 2018.</p>
<p>Finally, the guidelines reconfirm the EU’s desire to establish a close future partnership with the UK. As the UK enters the second phase of negotiations, its position on medicines regulation remains clear. The UK is fully committed to continuing the close working relationship with its European partners, in the interests of public health and safety. Its aim is to ensure that patients in the UK and across the EU continue to be able to access the best and most innovative medicines and be assured that their safety is protected through the strongest regulatory framework and sharing of data.</p>
<h3 id="preparing-for-all-outcomes">Preparing for all outcomes</h3>
<p>MHRA is aware that companies who market pharmaceuticals in the EU and UK will need to plan and make decisions in advance of the UK’s departure from the EU in March 2019.</p>
<p>As noted above, the UK’s intention remains to secure an implementation period based on the existing structure of EU rules and regulations as quickly as possible, and to agree a deep and special future partnership.</p>
<p>We will continue to advise businesses on the basis of the UK position and will continue to work with the European Medicines Agency in planning for the UK’s withdrawal from the EU and future relationship.</p>
<h3 id="current-regulatory-relationship-between-uk-and-european-network">Current regulatory relationship between UK and European network</h3>
<p>It is also important to note that the UK’s current regulatory relationship with the European network remains unchanged. The UK has underlined to Member States and to the EMA on several occasions that at present:</p>
<ul>
<li>
<p>the UK continues to be a full member of the EU: we will fulfil our responsibilities, and, in turn expect to be treated as such.</p>
</li>
<li>
<p>the UK continues to bid for EMA work and expects its bids to be respected and considered on merit. There are simple, pragmatic solutions to manage the possibility of various outcomes in March 2019: we are, for example, putting forward UK bids in conjunction with other Member States, in the centralised procedure, to ensure business continuity where procedures are likely to run beyond this date.</p>
</li>
<li>
<p>MHRA have committed to complete all assessments under evaluation at the time that the UK departs from the EU and will make assessment reports available to the network.</p>
</li>
<li>
<p>the UK continues to carry out its Official Control Authority Batch Release (OCABR) responsibilities as part of the Official Medicines Control Laboratory (OMCL) network for human biologicals.</p>
</li>
<li>
<p>the UK will continue to put candidates forward for leadership roles where appropriate and expects the committees with responsibility for electing chairs to do so on merit.</p>
</li>
</ul>
<h3 id="uk-regulatory-requirements-after-march-2019-in-the-event-of-no-ongoing-relationship-with-ema-networks">UK regulatory requirements after March 2019 in the event of no ongoing relationship with EMA networks</h3>
<p>Companies have been asking for detail about UK legislative requirements in different scenarios. We have been working closely with industry associations and other stakeholders and further details on all these issues and more – both our Day One and longer-term proposals – will be published when appropriate.</p>
<p>As stated above, the UK intends to agree a time-limited implementation period with the EU, and both parties have recognised its importance. Should however there be no implementation period, MHRA’s approach would be in line with the following principles:</p>
<ul>
<li>
<p>the European Union (Withdrawal) Bill will convert the existing EU legislative framework into UK law at the moment of exit, so there would be no sudden changes to the UK regulatory framework.</p>
</li>
<li>
<p>we would be pragmatic in establishing UK regulatory requirements. We would give adequate notice and ensure that companies had sufficient time to implement any changed requirements.</p>
</li>
<li>
<p>where possible, we would be making use of the information we already have to complete administrative tasks for continuity of work and licences.</p>
</li>
<li>
<p>we would ensure the minimum disruption and burden on companies as the UK exits the EU, while building on the existing relationship between MHRA and firms.</p>
</li>
</ul>
<p>We will continue to engage with business, patient groups and other stakeholders to help plan ahead with certainty, and will look to publish more technical detail if appropriate.</p>
</div>tag:www.gov.uk,2005:AnnouncementPresenter/3754742018-01-11T10:59:27+00:002018-01-11T10:59:27+00:00News story: MHRA streamlines services for devices customersThe Medicines & Healthcare products Regulatory Agency (MHRA) has launched a new online service to support customers of the devices division<div class="govspeak"><p>At MHRA we are always working to improve the transparency, responsiveness, usability and effectiveness of our services.</p>
<p>To make our systems easier to use, we have developed and successfully piloted a new online service which:</p>
<ul>
<li>offers customers a better way to do business with us</li>
<li>provides a single online account with the Agency</li>
<li>provides access to Devices Registration (DR) and Certificates of Free Sale (CFS) services via a new online portal</li>
<li>allows our staff to access and provide information to customers more quickly and in a more joined-up way</li>
<li>enhances our customer service to you</li>
</ul>
<h3 id="what-do-i-need-to-do">What do I need to do?</h3>
<p>Our new online accounts began being rolled out to customers at the end of November 2017 and we aim to have everyone on the new system by the end of February 2018.</p>
<p>If you use our Device Registration service or you apply for Certificates of Free Sale you will be moved to the new system in groups and will receive information with your instructions and go-live date.</p>
<p>There is no need to re-register. Your existing registration will remain valid and we will let you know what action you need to take to update your new account.</p>
<h3 id="further-information">Further information</h3>
<p><a rel="external" href="https://a.pgtb.me/vqRfCx">Read more about our new system.</a></p>
<p>If you have any further questions, please contact:
<a href="mailto:devices.transformation@mhra.gov.uk">devices.transformation@mhra.gov.uk</a></p>
<p><a rel="external" href="https://twitter.com/MHRAgovuk">@MHRAdevices</a></p>
</div>tag:www.gov.uk,2005:AnnouncementPresenter/3697242017-10-23T12:40:28+01:002017-10-23T12:40:28+01:00News story: Pharmacopoeial biological standards assure the quality of biological medicinesMHRA is releasing the response to January’s consultation on the strategy for pharmacopoeial public quality standards for biological medicines<div class="govspeak"><p>In January 2017, MHRA launched a <a href="https://www.gov.uk/government/consultations/strategy-for-pharmacopoeial-public-quality-standards-for-biological-medicines">public consultation on pharmacopoeial quality standards for biological medicines</a>.</p>
<p>The quality of biological medicines, which are an increasingly important part of healthcare worldwide, is assured by a regulatory framework which includes compliance to public quality standards. Documentary and physical standards work together to make sure biological medicines are of acceptable quality for use by patients.</p>
<p>The consultation posed specific questions to understand stakeholders’ perspectives on biological medicines, how biological quality standards should be developed, what they should look like and how they can enable innovation, and how the Agency can best engage with users. The consultation was received positively by stakeholders and a wide range of responses were received representing trade associations, manufacturers, academia/researchers and peer organisations.</p>
<p>The responses were analysed by a cross-Agency group, and the key themes of value and innovation, Agency role, alternative approaches and unmet needs, collaboration and international engagement were drawn out:</p>
<ul>
<li>Value and innovation: in general, responses supported the value of standardisation as an important activity in ensuring the quality of medicines</li>
<li>Agency role: the Agency, through its unique incorporation of the regulatory and standard setting functions (BP and NIBSC), is well placed to make an important contribution to the development of biological standards.</li>
<li>Alternative approaches and unmet needs: alternative approaches and unmet needs identified by stakeholders were focussed on standards for biotechnologically produced proteins, raw materials and ATMPs.</li>
<li>Collaboration: the opportunity to engage with the Agency on the draft strategy was commended and there was a clear desire for the Agency to continue to do this going forward, including offers of collaboration</li>
<li>International engagement: consistent throughout the responses was the need for MHRA to engage with, and influence, the international regulatory and standard setting environment</li>
</ul>
<p>The response document <a href="https://www.gov.uk/government/consultations/strategy-for-pharmacopoeial-public-quality-standards-for-biological-medicines">published today</a> sets out how the Agency plans to incorporate the feedback we received from stakeholders into its strategy and the resultant work programme.</p>
<p>The work programme relates to key activities we are committed to undertaking to implement our strategy for pharmacopoeial standards for biological medicines. The activities fall into 3 broad categories: standards development; engaging with users and building knowledge; our international peers. Key points are:</p>
<ul>
<li>Establishing three working parties with representatives from MHRA regulatory, British Pharmacopoeia, NIBSC and experts from industry and academia to explore alternative approaches, ATMPs and Raw materials</li>
<li>A number of activities to continually engage stakeholders in the work including a 2018 symposium
Maintaining our active roles and relationships internationally</li>
</ul>
<p>We would like to thank all those who shared their views with us. If you have any further questions on the consultation response, please contact us on <a href="mailto:BiolStandards@mhra.gov.uk">BiolStandards@mhra.gov.uk</a>.</p>
</div>tag:www.gov.uk,2005:AnnouncementPresenter/3680092017-09-29T09:36:00+01:002017-09-29T13:47:12+01:00News story: Improving collaboration to protect public health – MHRA and Care Quality Commission sign MoUThe Medicines and Healthcare products Regulatory Agency (MHRA) and Care Quality Commission (CQC) set out key principles to support their collaboration on improving public health.<p><em>Updated:</em> minor update in attachment</p><div class="govspeak"><p>Today we have set out how we will work more effectively with CQC in a new <span id="attachment_2312360" class="attachment-inline">
<a href="/government/uploads/system/uploads/attachment_data/file/648639/20170926_MHRA_CQC_MOU_FINAL.pdf">Memorandum of Understanding (MoU)</a>
(<span class="type"><abbr title="Portable Document Format">PDF</abbr></span>, <span class="file-size">200KB</span>, <span class="page-length">7 pages</span>)
</span>
.</p>
<p>CQC is the independent regulator of health and social care services in England. They also monitor the use of the Mental Health Act 1983 and protect the interests of people whose rights are restricted under the Act.</p>
<p>We have worked closely with CQC on alert systems, medicines issues and online healthcare services. Our working relationship helps maintain an effective regulatory system for health and adult social care in England, while promoting patient safety and high quality care.</p>
<p>The new MoU sets out the framework to support our joint working relationship. We agree on how to share information, to carry out regulatory functions and to benefit the public. These principles underpin the MoU:</p>
<ul>
<li>addressing overlaps and gaps in the regulatory framework and responsibilities</li>
<li>cooperating openly and transparently</li>
<li>respecting each other’s independent status</li>
<li>using resources and intelligence effectively and efficiently</li>
</ul>
<h3 id="notes-to-editor">Notes to Editor</h3>
<ol>
<li>The Memorandum of Understanding was signed by Mr David Behan, Chief Executive, CQC and Dr Ian Hudson, Chief Executive, MHRA.</li>
<li>MHRA is responsible for regulating all medicines and medical devices in the UK. All our work is underpinned by robust and fact-based judgments to ensure that the benefits justify any risks. MHRA is a centre of the Medicines and Healthcare products Regulatory Agency which also includes the <a rel="external" href="http://www.nibsc.org/">National Institute for Biological Standards and Control (NIBSC)</a> and the <a rel="external" href="https://www.cprd.com/intro.asp">Clinical Practice Research Datalink (CPRD)</a>. The Agency is an executive agency of the Department of Health. <a href="https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency">www.mhra.gov.uk</a>
</li>
</ol>
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<h3>Media enquiries</h3>
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<span class="fn">News centre</span><br>
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</p>
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<span class="type">During office hours:</span>
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<span class="type">Out of office hours:</span>
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<p class="comments">Office hours are Monday to Friday, 8:30am to 5pm. For real-time updates including the latest press releases and news statements, see our Twitter channel at <a href="https://www.twitter.com/mhrapress">https://www.twitter.com/mhrapress</a></p>
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</div>tag:www.gov.uk,2005:AnnouncementPresenter/3367882016-08-17T13:05:00+01:002017-09-27T11:34:07+01:00News story: Know what you're buying!Ten top tips for buying medicines and medical devices online safely<p><em>Updated:</em> Change of top tips content</p><div class="govspeak"><p>Medicines and medical devices are serious things. When you buy from dodgy websites or from someone not authorised to sell medicines online, this significantly increases your risk of buying a fake, which means you don’t know what you’re getting and you don’t know what it can do to your body.</p>
<p>We’ve put together these tips to help you reduce the risks to your health and money when you buy medical products online.</p>
<h3 id="look-for-the-distance-selling-logo">1. Look for the distance-selling logo</h3>
<p>All online retailers of medicines, operating legally in the EU, must display it. The most reliable way to ensure you are buying products from a registered and approved online seller of medicines is to click <a rel="external" href="https://medicine-seller-register.mhra.gov.uk/">here</a> to check the approved list.</p>
<figure class="image embedded"><div class="img"><img src="https://assets.publishing.service.gov.uk/government/uploads/system/uploads/image_data/file/71625/EU-distance-selling-logo-960x640.jpg" alt="Distance selling logo"></div></figure>
<h3 id="look-for-the-ce-mark-on-medical-devices">2. Look for the CE mark on medical devices</h3>
<p>A manufacturer displaying a CE mark on their medical device is saying their product complies with the essential regulatory requirements, designed to make sure products work as they’re supposed to and are acceptably safe.</p>
<figure class="image embedded"><div class="img"><img src="https://assets.publishing.service.gov.uk/government/uploads/system/uploads/image_data/file/71624/CE-mark-960x640.jpg" alt="CE Mark"></div></figure>
<h3 id="natural-does-not-mean-safe">3. “Natural” does not mean safe</h3>
<p>Products that claim to be ‘herbal’ or ‘all-natural’ can actually contain chemical ingredients. Each year we seize thousands of slimming products which claim to be herbal but contain sibutramine – a medicine which was withdrawn from sale due to serious side effects including strokes and heart attacks. Similarly, there are countless ‘herbal’ erectile dysfunction medications available online that could put your health at risk.</p>
<p>If you are unsure about the safety of a medicine claiming to be “natural” or “herbal” you should check for a Product Licence (PL) number or <a href="https://www.gov.uk/government/publications/herbal-medicines-granted-a-traditional-herbal-registration-thr/herbal-medicines-granted-a-traditional-herbal-registration">Traditional Herbal Registration (THR) number</a> / the THR logo. This means the product has been assessed by MHRA for safety and has been manufactured correctly. For more information, visit <a rel="external" href="http://www.nhs.uk/conditions/herbal-medicines/Pages/Introduction.aspx">NHS Choices</a>.</p>
<figure class="image embedded"><div class="img"><img src="https://assets.publishing.service.gov.uk/government/uploads/system/uploads/image_data/file/71692/THR-logo-framed-960x640.jpg" alt="THR logo"></div></figure>
<h3 id="check-for-secure-payment-options">4. Check for secure payment options</h3>
<p>When entering personal information, look out for a small padlock in the address bar or elsewhere in the frame of your browser (not the webpage itself). This will indicate that the information you enter will be encrypted and isn’t being stolen. If the padlock symbol is not present, do not enter your information.</p>
<figure class="image embedded"><div class="img"><img src="https://assets.publishing.service.gov.uk/government/uploads/system/uploads/image_data/file/71626/Padlock-secure-web-payment-960x640.jpg" alt="Padlock image"></div></figure>
<h3 id="check-the-small-print">5. Check the small print</h3>
<p>Scam sites often encourage you to sign up, committing you to hand over your money for a “trial”. In fact, you could be agreeing to a schedule of large regular payments from your account for useless or dangerous products. Read the small print carefully and know what you are signing up to.</p>
<h3 id="be-wise-to-gimmick-marketing">6. Be wise to gimmick marketing</h3>
<p>Terms like “detox” and “fat-melting” are meaningless, without any scientific or medical basis but they are the kind of words people selling dodgy slimming pills use to make you think their product will work.</p>
<h3 id="if-they-tell-you-its-safe-they-might-be-lying">7. If they tell you it’s safe, they might be lying</h3>
<p>Even if the people selling you a product assures you it’s safe, if it arrives with a label which reads “not for human consumption”, don’t take this under any circumstances. You have no way of knowing how your body is going to react – especially if the product has been designed for livestock!</p>
<h3 id="dont-self-diagnose">8. Don’t self-diagnose</h3>
<p>We know it is tempting to Google symptoms and self-diagnose but there there are many reasons why you should visit your healthcare professional if you believe you need medical treatment for something. A doctor can:</p>
<ul>
<li>give you their expert opinion about your condition and help work out the right treatment for you, in light of your medical history</li>
<li>prescribe you medicines which you can be sure have gone through the proper tests for safety and effectiveness – and importantly, you can be sure that it’s the real thing!</li>
</ul>
<h3 id="dodgy-website-design-can-mean-a-dodgy-website">9. Dodgy website design can mean a dodgy website</h3>
<p>Look for signs of scam websites put together by amateurs in a hurry. Poor design, pop-ups, spelling and grammar errors which may indicate poor translation, should all set off alarm bells. Checking reviews can also help you spot a scam site - but scammers often add their own fake reviews. The consumer association Which? have put together <a rel="external" href="http://www.which.co.uk/consumer-rights/advice/how-to-spot-a-fake-fraudulent-or-scam-website">a guide on how to spot genuine online reviews</a>.</p>
<h3 id="if-in-doubt-report-it">10. If in doubt, report it!</h3>
<p>If you suspect a website of selling fakes or think you’ve bought a fake medicine or medical device <a rel="external" href="https://medicine-seller-register.mhra.gov.uk/report?ref=">report it</a> to us.</p>
<p>You can also report to our <a rel="external" href="https://yellowcard.mhra.gov.uk/counterfeit-products/">Yellow Card</a> scheme if you:</p>
<ul>
<li>think you’ve experienced side effects from a suspected fake medicine</li>
<li>think you’ve experienced an unexpected or unwelcome consequence by using a suspected fake medical device</li>
</ul>
<figure class="image embedded"><div class="img"><img src="https://assets.publishing.service.gov.uk/government/uploads/system/uploads/image_data/file/71627/Yellow-Card-logo-960x640.jpg" alt="Yellow card scheme logo"></div></figure>
<p>This information will help us continue to seize fake medical products, close down websites that are putting people’s health at risk and prevent others from experiencing the problems you might have had.</p>
<h3 id="keep-in-touch-with-the-campaign">Keep in touch with the campaign</h3>
<p>Visit the <a rel="external" href="https://fakemeds.campaign.gov.uk/">campaign website</a>, or follow us on <a rel="external" href="https://twitter.com/MHRAgovuk?ref_src=twsrc%5Egoogle%7Ctwcamp%5Eserp%7Ctwgr%5Eauthor">@MHRAgovuk</a> using <a rel="external" href="https://twitter.com/hashtag/fakemeds">#FakeMeds</a>, and <a rel="external" href="https://www.facebook.com/mhragovuk/">Facebook</a>. There will be a range of videos and quick accessible tools to help you protect your health and money when you buy medical products online.</p>
</div>tag:www.gov.uk,2005:AnnouncementPresenter/3673302017-09-21T11:21:44+01:002017-09-21T11:21:44+01:00News story: MHRA statement on Essure devicesAdvice for women following the decision by Bayer to withdraw the Essure device from the European Market.<div class="govspeak"><p>Bayer has advised the Medicines and Healthcare products Regulatory Agency that they are withdrawing the Essure Device from the European Market.</p>
<p>The manufacturer has advised this is a commercial decision and is not related to any safety concerns and the device will continue to be available in the USA. They have also advised there is no need for women to have their device removed.</p>
<p>Patient safety is our highest priority and there is currently no evidence to suggest any increased risk to patient safety. Any women with questions should speak to their GP or healthcare professional.</p>
<p>We encourage any woman who has experienced a complication from her Essure device to report this to us through <a rel="external" href="http://www.mhra.gov.uk/yellowcard">the Yellow Card scheme</a>, regardless of how long ago the implant was inserted.</p>
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<h3>Media enquiries</h3>
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Victoria</span><br>
<span class="locality">London</span><br>
<span class="postal-code">SW1W 9SZ</span>
</p>
<div class="email-url-number">
<p class="email">
<span class="type">Email</span>
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<span class="type">During office hours:</span>
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</p>
<p class="tel">
<span class="type">Out of office hours:</span>
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<p class="comments">Office hours are Monday to Friday, 8:30am to 5pm. For real-time updates including the latest press releases and news statements, see our Twitter channel at <a href="https://www.twitter.com/mhrapress">https://www.twitter.com/mhrapress</a></p>
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</div>tag:www.gov.uk,2005:AnnouncementPresenter/3672112017-09-19T14:10:30+01:002017-09-19T14:10:30+01:00News story: MHRA delivers guidance on human factorsIn collaboration with key stakeholders, MHRA has produced guidance on the human factors aspects of design for medical devices including those in drug-device combination products.<div class="govspeak"><p><a href="https://www.gov.uk/government/publications/guidance-on-applying-human-factors-to-medical-devices">This guidance</a> is intended for manufacturers, developers and notified bodies to highlight the important influence human factors have on patient safety. The advice is also relevant to device components of drug-device combination products that are regulated as medicines.</p>
<p>Although it seeks to clarify regulatory expectations of medical devices marketed in the UK, the guidance does not represent a compliance requirement.</p>
<p>An engaging multi-disciplinary stakeholder day on human factors and the implications for patient safety led to the formation of the Human Factors Task and Finish group. The group was chaired by Dr Peter Nightingale, who is also the chair of MHRA Devices Expert Advisory Group (DEAC) and Tony Sant, group manager in the Devices Division, MHRA.</p>
<p>Membership was drawn from MHRA, academia, industry, NHS Improvement, NICE, notified bodies, professional associations and trade bodies, and the resulting guidance is the collective effort of that group and of feedback from further stakeholder engagement and the public consultation of a first draft published in June 2016.</p>
<p>In simple terms, ‘human factors’ refers to how a person will interact with the system surrounding them, including the technology they use. Human factors takes into account the environment, user population and potential competing distractions.</p>
<p>John Wilkinson, MHRA Devices director, praised the collaborative effort to produce the guidance.</p>
<p>“Medical devices are becoming ever more complex and diverse, encompassing drug-device combinations and companion diagnostics.</p>
<p>“Patient care is increasingly being transferred from hospitals to patient homes and community settings. As these developments occur the potential for use error increases. We recognise this and have collaborated with partners to produce the first UK guidance on human factors.”</p>
<p>This guidance will complement the work being carried out by the NHS to apply human factors approaches in the design of healthcare workplaces and practices.</p>
<p>View the <a href="https://www.gov.uk/government/publications/guidance-on-applying-human-factors-to-medical-devices">complete guidance</a>.</p>
<p>Find us on Twitter <a rel="external" href="https://twitter.com/MHRAgovuk">@MHRAgovuk</a> <a rel="external" href="https://twitter.com/hashtag/ThinkPatientSafety?src=hash">#ThinkPatientSafety</a></p>
</div>tag:www.gov.uk,2005:AnnouncementPresenter/3671492017-09-18T12:53:00+01:002017-09-18T12:53:00+01:00News story: Help us understand your needs and priorities: MHRA launches customer surveyThe Medicines and Healthcare products Regulatory Agency is conducting a survey to better understand how it can support its customers<div class="govspeak"><p>As part of our continued commitment to deliver a high-quality service to our customers, stakeholders and partners, the Medicines and Healthcare products Regulatory Agency is embarking on a major operational transformation programme across all three of our expert centres – the MHRA regulatory centre, the <a rel="external" href="http://www.nibsc.org/">National Institute for Biological Standards and Control (NIBSC)</a> and the <a rel="external" href="https://www.cprd.com/intro.asp">Clinical Practice Research Datalink (CPRD)</a>. This includes significant investment in our digital capabilities and infrastructure.</p>
<p>Understanding your needs and priorities is essential to inform our plans and will help us to strategically shape our services, investment decisions and underlying operational processes and systems. The work we do now will underpin how we are able to meet your needs for years to come.</p>
<p>To help us gain this insight, we have developed a <a rel="external" href="https://www.surveymonkey.co.uk/r/MHRA2017B">short online survey</a> – in collaboration with PA Consulting, a consulting, technology and innovation firm, and Woodnewton Associates, an independent strategic research agency – to help us understand more about your experience of working with us and your views on where and how we need to do things differently.</p>
<p>The survey should take about 10-15 minutes to complete, depending on how many different parts of the Agency you deal with. In line with the rules of the UK Market Research Society, your contribution will be held in strict confidence and information will not be passed to us in a way that would allow any individual contribution to be identified. You can forward the survey on to others who you think would like to share their views with us.</p>
<p>The survey closes on Wednesday 27 September.</p>
<div class="call-to-action">
<p><a rel="external" href="https://www.surveymonkey.co.uk/r/MHRA2017B">Complete our survey now</a></p>
</div>
</div>tag:www.gov.uk,2005:AnnouncementPresenter/3649782017-08-17T12:34:00+01:002017-08-17T12:34:00+01:00News story: MHRA successfully reclassifies Dovonex Psoriasis OintmentMedicines and Healthcare products Regulatory Agency (MHRA) have today announced the approval of Dovonex Psoriasis 50microgram/g Ointment, which will be available through pharmacies without prescription.<div class="govspeak"><p>Following a successful public consultation, Dovonex Psoriasis Ointment will be available through pharmacies without a prescription.</p>
<p>The Commission on Human Medicines (CHM) advised in favour of the product being available in pharmacies for the treatment of mild to moderate plaque psoriasis which has been previously diagnosed by a doctor in adults aged 18 years and over. The treatment is for application once daily, with maximum duration of use of 12 weeks and maximum pack size of 60g of ointment.</p>
<p>Pharmacists are trained healthcare professionals and will have access to training materials to enable them to identify patients that can be supplied this medicine with reasonable safety.</p>
<p>MHRA always want to encourage people to be involved in their healthcare and are in the process of holding public consultations for conditions that are suitable for self-care. Further information on reclassification can be found <a href="https://www.gov.uk/guidance/medicines-reclassify-your-product">here</a>.</p>
</div>tag:www.gov.uk,2005:AnnouncementPresenter/3647382017-08-15T12:00:34+01:002017-08-15T12:00:34+01:00News story: Making safer polio vaccines with plantsA new study, involving scientists from National Institute for Biological Standards and Control (NIBSC), has reported the production of stable poliovirus virus-like particles (VLPs) in plants.<div class="govspeak"><p>The research, <a rel="external" href="https://www.nature.com/articles/doi:10.1038/s41467-017-00090-w">published in the journal Nature Communications</a>, confirms that these plant-made particles are structurally similar to poliovirus and can protect mice from infection as effectively as existing vaccines.</p>
<p>As large amounts of live poliovirus are needed to make current vaccines, VLP-based vaccines could provide a safer alternative for vaccine production after polio eradication.</p>
<h3 id="what-are-vlps">What are <abbr title="virus-like particles">VLPs</abbr>?</h3>
<p><abbr title="virus-like particles">VLPs</abbr> are empty protein shells that ‘mimic’ the virus but lack the genetic material needed for replication.
Scientists have suggested poliovirus <abbr title="virus-like particles">VLPs</abbr> as potential vaccine candidates because they can provoke an immune response but aren’t infectious. However, their instability has long been a barrier for their use as vaccines.</p>
<p>In January, <a rel="external" href="http://www.nibsc.org/about_us/latest_news/new_technique.aspx"><abbr title="National Institute for Biological Standards and Control">NIBSC</abbr> researchers published a new genetic approach to make stable poliovirus <abbr title="virus-like particles">VLPs</abbr></a>, which forms the basis of this new study.</p>
<h3 id="using-plants-to-make-medicines">Using plants to make medicines</h3>
<p>Over the last 20 years, plants have begun to compete with bacteria, yeast, insect and mammalian cells as producers of medicines and they’ve recently been used to make candidate VLP-based vaccines against infectious diseases such as influenza.</p>
<p>For this study, researchers expressed stabilised poliovirus <abbr title="virus-like particles">VLPs</abbr> in plants and compared them to normal, or ‘wild-type’, poliovirus.</p>
<p>They found that plant-produced stabilised <abbr title="virus-like particles">VLPs</abbr> had a similar structure to wild-type poliovirus and could promote similar levels of protective proteins, known as antibodies, as an existing vaccine.</p>
<p><a rel="external" href="https://www.nature.com/articles/doi:10.1038/s41467-017-00090-w">This paper</a> suggests plants could be used to make large quantities of stable and effective poliovirus <abbr title="virus-like particles">VLPs</abbr> for new vaccines.</p>
<p>The research is a collaboration between scientists at the John Innes Centre, <abbr title="National Institute for Biological Standards and Control">NIBSC</abbr>, University of Oxford, Diamond Light Source and University of Leeds and funded by the World Health Organisation (WHO).</p>
<p><abbr title="National Institute for Biological Standards and Control">NIBSC</abbr> researcher, and study author, Dr Andrew Macadam said:</p>
<blockquote>
<p>Current vaccines for polio are produced from large amounts of live virus which carries a threat of accidental escape and re-introduction. As <abbr title="virus-like particles">VLPs</abbr> aren’t infectious, making vaccines using these particles is safer and could be particularly important post-eradication.</p>
<p>This research shows that plants can be used to successfully make stable <abbr title="virus-like particles">VLPs</abbr> for vaccines. It takes us a step closer to replacing current polio vaccines, providing us with a cheap and viable option for making VLP-based vaccines.</p>
<p class="last-child">But the possibilities of this approach could extend further than polio and we’re also looking at applying these methods to develop stable <abbr title="virus-like particles">VLPs</abbr> for new vaccines against other viruses.</p>
</blockquote>
</div>tag:www.gov.uk,2005:AnnouncementPresenter/3643952017-08-08T14:26:29+01:002017-08-08T14:26:29+01:00News story: Professor Sir Michael Rawlins re-appointed ChairProfessor Sir Michael will return as Chair for a second term.<div class="govspeak"><p>The Medicines and Healthcare products Regulatory Agency announced the re-appointment of Professor Sir Michael Rawlins as its Chair yesterday for a further 3 years.</p>
<p>Since taking up the position of chair at the Agency in 2014, Sir Michael has overseen the Agency’s work as an effective regulator of medicines and medical devices across the UK. He has promoted the first-class science and research carried out in each of the Agency’s centres; the National Institute for Biological Standards and Control (NIBSC), the Clinical Practice Research Datalink (CPRD) and MHRA.</p>
<p>Earlier this year, Professor Sir Michael Rawlins was appointed Knight Grand Cross of the Order of the British Empire (GBE) for the services to the safety of medicines, healthcare and innovation.</p>
<p>Professor Sir Michael Rawlins said:</p>
<p>“I am delighted to serve as the Agency’s Chair for a second term. One of the joys of this job is seeing each part of the Agency continue to deliver innovative science and protect public health.</p>
<p>“I am looking forward to taking on the next challenge, as we seek to continue to play a leading role in both Europe and the world on promoting public health.”</p>
<p>Chief Executive Dr Ian Hudson said:</p>
<p>“Sir Mike has overseen a very successful period in the Agency’s history, and I’m delighted to see his re-appointment, as we move into an equally crucial next stage.</p>
<p>“He has been at the forefront of innovation, development and leadership in the public health sector for more than 3 decades.”</p>
<div class="contact postal-address" id="contact_2345">
<div class="content">
<h3>Media enquiries</h3>
<div class="vcard contact-inner">
<p class="adr">
<span class="fn">News centre</span><br>
<span class="street-address">MHRA
<br>
151 Buckingham Palace Road
<br>
Victoria</span><br>
<span class="locality">London</span><br>
<span class="postal-code">SW1W 9SZ</span>
</p>
<div class="email-url-number">
<p class="email">
<span class="type">Email</span>
<a class="email" href="mailto:newscentre@mhra.gov.uk">newscentre@mhra.gov.uk</a>
</p>
<p class="tel">
<span class="type">During office hours:</span>
020 3080 7651 (08:30 - 17:00)
</p>
<p class="tel">
<span class="type">Out of office hours:</span>
07770 446 189 (17:00 - 08:30)
</p>
</div>
<p class="comments">Office hours are Monday to Friday, 8:30am to 5pm. For real-time updates including the latest press releases and news statements, see our Twitter channel at <a href="https://www.twitter.com/mhrapress">https://www.twitter.com/mhrapress</a></p>
</div>
</div>
</div>
</div>tag:www.gov.uk,2005:AnnouncementPresenter/3634102017-07-26T12:07:38+01:002017-07-26T12:07:38+01:00News story: MHRA response to the final report of the Mesh Oversight GroupNHS England set up the Mesh Working Group to address the concerns of a number of patients and clinicians.<div class="govspeak"><p>John Wilkinson, Director of Devices at MHRA, said:</p>
<blockquote>
<p>Patient safety is our highest priority and we sympathise with women who have suffered complications after surgery.</p>
<p>We are committed to helping address the serious concerns raised by some patients. We have undertaken work to assess the findings of studies undertaken by the clinical community over many years, as well as considering the feedback from all sources in that time.</p>
<p>What we continue to see is that evidence supports the use of these devices in the UK for treatment of the distressing conditions of incontinence and organ prolapse in appropriate circumstances. This is supported by the greater proportion of the clinical community and patients.</p>
<p>In common with other medical device regulators worldwide, none of whom have removed these devices from the market, we are not aware of a robust body of evidence which would lead to the conclusion these devices are unsafe if used as intended.</p>
<p class="last-child">We actively encourage patients and healthcare professionals to <a href="https://www.gov.uk/report-problem-medicine-medical-device">report complications associated with these implants</a> through the <a rel="external" href="https://www.mhra.gov.uk/yellowcard">Yellow Card Scheme</a>.</p>
</blockquote>
<p>The final report of the NHS England-led Mesh Working Group can be found on the <a rel="external" href="https://www.england.nhs.uk/publication/mesh-oversight-group-report/">NHS England website</a>.</p>
<p>In 2014 MHRA also produced a <a href="https://www.gov.uk/government/publications/vaginal-mesh-implants-summary-of-benefits-and-risks">summary report of the evidence on the benefits and risks of vaginal mesh implants</a> as part of ongoing research.</p>
</div>tag:www.gov.uk,2005:AnnouncementPresenter/3615942017-07-10T10:56:46+01:002017-07-10T10:56:46+01:00News story: Successful reclassification of Nasonex Allergy Control Nasal SprayMHRA reclassifies Nasonex Allergy Control<div class="govspeak"><p>Nasonex Allergy Control 0.05% Nasal Spray will soon be available to buy over the counter in pharmacies following a public consultation by the Medicines and Healthcare products Regulatory Agency (MHRA). This nasal spray is used to treat the symptoms of allergic rhinitis such as sneezing and a runny, itchy or blocked up nose which may be caused by hay fever.</p>
<p>Nasonex Allergy Control is a nasal spray containing an active ingredient called mometasone furoate. This is the first product containing mometasone furoate to be available without prescription.
MHRA are committed to involving people in their healthcare, and to widen access to medicines for the benefit of public health when it is safe to do.</p>
</div>tag:www.gov.uk,2005:AnnouncementPresenter/3611452017-07-05T12:13:03+01:002017-07-05T12:13:03+01:00News story: Nasal decongestant to be available to buy from pharmaciesMHRA reclassifies Otrivine Extra Dual Relief Nasal Spray Solution<div class="govspeak"><p>The Medicines and Healthcare products Regulatory Agency has today agreed that Otrivine Extra Dual Relief Nasal Spray Solution will be available through pharmacies without prescription.</p>
<p>Otrivine Extra Dual Relief Nasal Spray contains Ipratropium bromide 0.6mg/ml and xylometazoline hydrochloride 0.5mg/ml.</p>
<p>Following a public consultation, MHRA has agreed to reclassify Otrivine Extra Dual Relief Nasal Spray Solution from a Prescription Only Medicine (POM) to a Pharmacy (P) medicine in the UK for the symptomatic treatment of nasal congestion and rhinorrhoea in connection with common colds.</p>
<p>MHRA is committed to improving access to medicines where it is safe to do so, providing greater choice and better access for the public.</p>
</div>tag:www.gov.uk,2005:AnnouncementPresenter/3609492017-07-03T14:34:51+01:002017-07-03T14:34:51+01:00News story: Maloff Protect successfully reclassifiedAfter a public consultation, Maloff Protect will now be available over the counter in pharmacies<div class="govspeak"><p>Maloff Protect anti-malaria tablets are now available to buy from pharmacies, after previously only being available to purchase with a prescription.</p>
<p>The news follows a successful public consultation, where members of the public were asked to contribute their say on the availability of the product.</p>
<p>The tablets will be available to adults aged over 18 weighing more than 40kg travelling to areas where malaria is widespread.</p>
<p>Patients must tell their pharmacist which countries they will be visiting: it is essential that to take an antimalarial that will be effective in those areas. You will need to start the tablets before arriving in a malaria-endemic area and to continue taking them for 7 days after leaving.</p>
<p>A final decision was made by MHRA, on behalf of the UK Licensing Authority, after responses from the public consultation were analysed.</p>
<p>Following a stringent assessment procedure, The Commission on Human Medicines (CHM) recommended reclassifying the tablets for those travelling in areas where malaria is common.</p>
<p>MHRA always want to encourage people to be involved in their healthcare and are in the process of holding public consultations for conditions that are suitable for self-care.</p>
<p>Maloff Protect was one of a number of medicines currently being considered for reclassification as an over the counter medicine, to help widen access to medicines for the benefit of public health when it is safe to do.</p>
</div>tag:www.gov.uk,2005:AnnouncementPresenter/3597372017-06-20T16:04:50+01:002017-06-20T16:04:50+01:00News story: MHRA chair recognised in 2017 Queen's Birthday HonoursProfessor Sir Michael Rawlins, MHRA chair, honoured in the 2017 Queen's Birthday Honours List.<div class="govspeak"><p>We are delighted that the chair of the Medicines and Healthcare products Regulatory Agency (MHRA), Professor Sir Michael Rawlins, has been appointed Knight Grand Cross of the Order of the British Empire (GBE).</p>
<p>The honour, which was announced in the 2017 Birthday Honours List over the weekend, is for services to the safety of medicines, healthcare and innovation and comes after more than three decades at the forefront of innovation, development and leadership in the public health sector.</p>
<p>Since taking up the position of chair at MHRA in 2014 Sir Michael has overseen the Agency’s work as an effective regulator of medicines and medical devices across the UK. He has promoted the first-class science and research carried out in each of the Agency’s centres; the National Institute for Biological Standards and Control (NIBSC), the Clinical Practice Research Datalink (CPRD) and MHRA.</p>
<p>Professor Sir Michael Rawlins said:</p>
<blockquote>
<p>It is a tremendous honour to receive this prestigious award, and is a great recognition of the work the Agency carries out to protect public health.</p>
<p class="last-child">Innovation has been a key focus for the Agency over the past few years with the launch of our Innovation Office and the early access to medicines scheme (EAMS), and I have been proud to have been part of this beneficial development in the health sector.</p>
</blockquote>
<h3 id="background">Background</h3>
<ol>
<li>
<p>Sir Michael Rawlins, currently chair of the Medicines and Healthcare Products Regulatory Agency and also UK Biobank, was the founding Chair of the National Institute for Clinical Excellence. Under his leadership, NICE became an internationally renowned organisation, pioneering processes which have been copied the world over. It has facilitated faster NHS uptake of new technologies and procedures, offering opportunities to patients in a way not experienced before. He has previously served as Chair of the Advisory Council on the Misuse of Drugs and President of the Royal Society of Medicine.</p>
</li>
<li>
<p>The <a href="https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency">Medicines and Healthcare products Regulatory Agency</a> is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks. MHRA is a centre of the Medicines and Healthcare products Regulatory Agency which also includes the <a rel="external" href="http://www.nibsc.org/">National Institute for Biological Standards and Control (NIBSC)</a> and the <a rel="external" href="http://www.cprd.com/intro.asp">Clinical Practice Research Datalink (CPRD)</a>. MHRA is an executive agency of the <a href="https://www.gov.uk/government/organisations/department-of-health">Department of Health</a>.</p>
</li>
</ol>
<div class="contact postal-address" id="contact_2345">
<div class="content">
<h3>Media enquiries</h3>
<div class="vcard contact-inner">
<p class="adr">
<span class="fn">News centre</span><br>
<span class="street-address">MHRA
<br>
151 Buckingham Palace Road
<br>
Victoria</span><br>
<span class="locality">London</span><br>
<span class="postal-code">SW1W 9SZ</span>
</p>
<div class="email-url-number">
<p class="email">
<span class="type">Email</span>
<a class="email" href="mailto:newscentre@mhra.gov.uk">newscentre@mhra.gov.uk</a>
</p>
<p class="tel">
<span class="type">During office hours:</span>
020 3080 7651 (08:30 - 17:00)
</p>
<p class="tel">
<span class="type">Out of office hours:</span>
07770 446 189 (17:00 - 08:30)
</p>
</div>
<p class="comments">Office hours are Monday to Friday, 8:30am to 5pm. For real-time updates including the latest press releases and news statements, see our Twitter channel at <a href="https://www.twitter.com/mhrapress">https://www.twitter.com/mhrapress</a></p>
</div>
</div>
</div>
</div>tag:www.gov.uk,2005:AnnouncementPresenter/3564532017-04-10T09:00:42+01:002017-04-10T09:00:42+01:00News story: Losing GSI – MHRA emails are changingFrom 10 April, we are removing .gsi from our email addresses. <div class="govspeak"><p>Launched in 1996, the Government Secure Intranet (GSi) has been used until now to guarantee the security of emails sent by Government agencies and Arms Length Bodies.
Technology has changed a lot since 1996 and the GSi is now being phased out across Government.</p>
<h4 id="whats-changing">What’s changing?</h4>
<div class="call-to-action">
<p>From 10 April 2017 we are removing .gsi from our mhra email addresses
So <a href="mailto:info@mhra.gsi.gov.uk">info@mhra.gsi.gov.uk</a> will now be <a href="mailto:info@mhra.gov.uk">info@mhra.gov.uk</a></p>
</div>
<p>Our new email addresses will be more secure, and the new system will protect against anyone trying to forge our domain name (the @mhra bit) and sending emails that claim to be from MHRA.</p>
<h4 id="what-do-i-need-to-do">What do I need to do?</h4>
<div class="call-to-action">
<p>Update your MHRA email contacts and remove .gsi from our email addresses.
Update any tools that use MHRA email addresses</p>
</div>
<p>Emails sent to email addresses including the .gsi will continue to be forwarded until further notice.</p>
<p>If you have any questions about this change or require more information please contact us on <a href="mailto:info@mhra.gov.uk">info@mhra.gov.uk</a></p>
<p>This change only affects email addresses ending in mhra.gsi.gov.uk –all email addresses ending in nibsc.org will remain the same.</p>
</div>tag:www.gov.uk,2005:AnnouncementPresenter/3558182017-03-31T15:54:00+01:002017-03-31T15:54:00+01:00News story: A new way to payPaying for medicines licences, clinical trials and clinical investigations is changing from 1 April the Medicines and Healthcare products Regulatory Agency (MHRA) announced.<div class="govspeak"><p>Instead of paying in advance, a new ‘Pay on Invoice’ process will streamline the way we manage a range of applications.</p>
<p>We are committed to reducing the regulatory burden and improving the process for licence applications.</p>
<p>From 1 April those making applications will no longer need to attach proof of payment making the end-to-end process simpler, easier and quicker.</p>
<p>The benefits of the new process include removing the need to work out complex fees and reducing the chance of applications being rejected for incorrect payment details.</p>
<p>Additionally the simplified payment process should result in fewer delays and make it easier for companies to reconcile financial records and accounts.</p>
<p>Overall the process is aimed at saving companies time and money.</p>
<p>Richard Humphreys, MHRA’s Deputy Director of Finance said:</p>
<blockquote>
<p>We have listened to our customers and launched this new project in order to make the process of payment much easier and quicker.</p>
<p>We hope the new process will reduce the regulatory burden and reduce unnecessary delays.</p>
<p class="last-child">As with everything we do, we welcome your feedback.</p>
</blockquote>
<p>If you have any questions please get in touch by emailing <a href="mailto:sales.invoices@mhra.gov.uk">sales.invoices@mhra.gov.uk</a></p>
<h2 id="further-information">Further information</h2>
<p>There have been no changes to our payment terms and invoices must be settled on receipt of invoice. Penalty fees can be incurred for non-payment, details of the penalties are set out in the Fees Regulations. Non-payment may also result in suspension of any licence or authorisation, followed by legal proceedings for unpaid amounts, as a debt due to the Crown.</p>
<p>More information can be found <a href="https://www.gov.uk/guidance/make-a-payment-to-mhra">here</a></p>
</div>tag:www.gov.uk,2005:AnnouncementPresenter/3521172017-02-28T09:56:47+00:002017-02-28T09:56:47+00:00News story: New essential Orange and Green Guides 2017 – out nowThe Medicines and Healthcare products Regulatory Agency has launched its latest guide of UK pharmaceutical regulations, EU directives and guidance. <div class="govspeak"><p>Aimed at manufacturers and distributors of human medicines the Orange and Green Guides have been revised and updated to keep industry informed of the latest regulations.</p>
<p>The <a rel="external" href="http://www.pharmpress.com/product/9780857112859/orangeguide?utm_source=mhra_email&amp;utm_campaign=orange17&amp;utm_medium=email">Orange Guide (Rules and Guidance for Pharmaceutical Manufacturers and Distributors)</a>, now in its tenth edition, contains information and legislation relating to the manufacture and distribution of human medicines.</p>
<p>The <a rel="external" href="http://www.pharmpress.com/product/9780857112866/green?utm_source=mhra_email&amp;utm_campaign=green17&amp;utm_medium=email">Green Guide (Rules and Guidance for Pharmaceutical Distributors)</a> provides information on the broader distribution of human medicines.</p>
<p>Mark Birse, Group Manager in <abbr title="Medicines and Healthcare products Regulatory Agency">MHRA</abbr>’s Inspection, Enforcement and Standard Division said:</p>
<blockquote>
<p class="last-child">Ensuring that safe and high quality medicines are being made and distributed is vitally important.</p>
</blockquote>
<blockquote>
<p class="last-child">This provides the trust needed by patients and healthcare professionals to use them.</p>
</blockquote>
<blockquote>
<p class="last-child">Both new editions have been revised and updated with the latest pharmaceutical regulations, directives and guidance.</p>
</blockquote>
<blockquote>
<p class="last-child">These updated guides will help companies understand the regulatory environment in which they operate, follow good practice and stay compliant with the law.</p>
</blockquote>
<p>The new 2017 edition of the Orange Guide has been updated to incorporate changes and additions made to the detailed European Community guidelines on Good Manufacturing Practice (GMP) and the revised EU Guidelines on Good Distribution Practice (GDP).</p>
<p>There are new sections on:</p>
<ul>
<li>GMP for excipients</li>
<li>guidance on revised Annex 16 of GMP</li>
<li>data Integrity definitions and guidance for industry</li>
</ul>
<p>The new 2017 edition of the Green Guide provides a single source of guidance to, and legislation for, the distribution of medicines in Europe and UK.</p>
<p>There are new sections on:</p>
<ul>
<li>the guidelines on principles of Good Distribution Practice of active substances for medicinal products for human use (2015/C 95/01)</li>
<li>matters relating to unlicensed medicines</li>
<li>sourcing and exporting medicinal products – non-EEA countries</li>
<li>data integrity</li>
<li>the EU regulation on safety features for medicines</li>
</ul>
<h2 id="order-the-orange-and-green-guides">Order the Orange and Green Guides</h2>
<p>The Orange and Green Guides are available to be ordered from <a rel="external" href="http://www.pharmpress.com/Orange-Green-Guides">Pharmaceutical Press.</a> They are also both available online via <a rel="external" href="https://www.medicinescomplete.com/about/?utm_source=mhra_email&amp;utm_campaign=orange17&amp;utm_medium=email">MedicinesComplete</a></p>
<h2 id="background">Background</h2>
<ol>
<li>
<a href="https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency">Medicines and Healthcare products Regulatory Agency</a>
is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks. <abbr title="Medicines and Healthcare products Regulatory Agency">MHRA</abbr> is a centre of the Medicines and Healthcare products Regulatory Agency which also includes the <a rel="external" href="http://www.nibsc.org">National Institute for Biological Standards and Control (NIBSC)</a> and the <a rel="external" href="http://www.cprd.com/intro.asp">Clinical Practice Research Datalink (CPRD)</a>. <abbr title="Medicines and Healthcare products Regulatory Agency">MHRA</abbr> is an executive agency of the Department of Health.</li>
</ol>
<div class="contact postal-address" id="contact_2345">
<div class="content">
<h3>Media enquiries</h3>
<div class="vcard contact-inner">
<p class="adr">
<span class="fn">News centre</span><br>
<span class="street-address"><abbr title="Medicines and Healthcare products Regulatory Agency">MHRA</abbr>
<br>
151 Buckingham Palace Road
<br>
Victoria</span><br>
<span class="locality">London</span><br>
<span class="postal-code">SW1W 9SZ</span>
</p>
<div class="email-url-number">
<p class="email">
<span class="type">Email</span>
<a class="email" href="mailto:newscentre@mhra.gov.uk">newscentre@mhra.gov.uk</a>
</p>
<p class="tel">
<span class="type">During office hours:</span>
020 3080 7651 (08:30 - 17:00)
</p>
<p class="tel">
<span class="type">Out of office hours:</span>
07770 446 189 (17:00 - 08:30)
</p>
</div>
<p class="comments">Office hours are Monday to Friday, 8:30am to 5pm. For real-time updates including the latest press releases and news statements, see our Twitter channel at <a href="https://www.twitter.com/mhrapress">https://www.twitter.com/mhrapress</a></p>
</div>
</div>
</div>
</div>tag:www.gov.uk,2005:AnnouncementPresenter/3503952017-02-09T10:21:39+00:002017-02-09T10:21:39+00:00News story: New MedRegs blogMHRA has launched an official blog providing expert insight into the latest regulatory thinking and all aspects of medicines regulation.<div class="govspeak"><p>If you’re working to develop and submit applications to MHRA for marketing authorisations and clinical trial authorisations, then you need to keep up to date with the latest regulatory thinking and be able to easily avoid common pitfalls.</p>
<p><a rel="external" href="https://medregs.blog.gov.uk/">Visit the MedRegs blog</a></p>
<p>Our blog will feature posts from experts who work right across the regulatory process. They’ll share their top insights and experience on a range of topics to help you stay informed, engage with our processes more effectively, and find out more about what we do to protect public health</p>
<p>We will be covering topics such as:</p>
<ul>
<li>submissions – how to get them right first time</li>
<li>behind the scenes – find out more about how the regulator works</li>
<li>key issues – the inside track on emerging issues for the regulation of medicines</li>
</ul>
<p>Dr Siu Ping Lam, Director of Licensing, MHRA said:</p>
<blockquote>
<p>Our MedRegs blog is another opportunity for us to connect directly with our stakeholders and customers in a less formal way, help them avoid common and easily avoidable errors and engage with us on issues that are important to them.</p>
<p class="last-child">It also offers them an opportunity to share their thoughts and comments with us, and will encourage further two-way conversation between our regulatory specialists at MHRA and those working across industry, academia and healthcare.</p>
</blockquote>
<p>We’d like to know what you think about our posts, so we can develop a really useful and informative blog. Let us know if you have ideas about what would be useful for us to cover.</p>
<p><a rel="external" href="https://medregs.blog.gov.uk/">Sign up to get new post alerts</a></p>
<p>Look us up on <a rel="external" href="https://www.facebook.com/mhragovuk/">Facebook</a>, <a rel="external" href="https://www.linkedin.com/company/medicines-and-healthcare-products-regulatory-agency">LinkedIn</a>, or <a rel="external" href="https://twitter.com/MHRAgovuk/">@MHRAgovuk</a> on Twitter</p>
</div>tag:www.gov.uk,2005:AnnouncementPresenter/3499712017-01-30T09:04:00+00:002017-01-30T09:04:00+00:00News story: MHRA launch 'DMAA Week of Action'MHRA has launched a ‘Week of Action’ to improve awareness of unlicensed medicines containing the potentially dangerous ingredient DMAA.<div class="govspeak"><p>The Medicines and Healthcare products Regulatory Agency has launched a ‘Week of Action’ between 30th January and 5th February aimed at improving awareness of unlicensed medicines containing the potentially dangerous ingredient DMAA.</p>
<p>The week of action aims to improve public awareness and encourages consumers of sports supplements to check to see if their products contain DMAA or any alternative names of the potentially dangerous ingredient. It includes an animated social media campaign, health &amp; fitness bloggers sharing their stories and a video with Dr Chris Jones and weightlifters.</p>
<p>MHRA visited the National Sports Stadium in Crystal Palace with British Weight Lifting, and spoke with Team GB weightlifter <a rel="external" href="http://britishweightlifting.org/performance/gb-athletes/mercy-brown/">Mercy Brown</a> and Commonwealth medallist <a rel="external" href="https://www.instagram.com/forrester_osei/">Forrester Osei</a>.</p>
<p>A number of leading national organisations have supported the week, including British Weightlifting, UK Anti-Doping, ESSNA, UK Active, National Food Crime Unit and Sporting Integrity Ltd.</p>
<p><a rel="external" href="https://www.youtube.com/watch?v=szhhi6iPxmk">Dr Chris Jones interview</a></p>
<p>You can check if your supplement contains DMAA by checking the <a rel="external" href="http://www.globaldro.com/UK/Search/Terms">global DRO list</a>, by entering a sport and searching for ‘DMAA’ and looking at the alternative names of the ingredient.</p>
<p>If you suspect your supplement contains DMAA, or it is being sold in the UK, then please email us at <a href="mailto:dmaa@mhra.gov.uk">dmaa@mhra.gov.uk</a></p>
<p>We will always investigate instances of the sale and supply of unauthorised medicinal products, including those that may be present in sports supplements.</p>
<p>Any offence committed under the Human Medicines Regulations 2012 could lead to prosecution.</p>
</div>tag:www.gov.uk,2005:AnnouncementPresenter/3482282017-01-09T11:22:00+00:002017-01-09T11:22:00+00:00News story: Standards for biological medicines - understanding them and how they make a differenceThe quality of biological medicines is assured by biological standards held by the British Pharmacopoeia (BP) and the National Institute for Biological Standards and Control (NIBSC)<div class="govspeak"><p>Biological medicines are an increasingly important part of healthcare. Our role as medicines regulator is to make sure the medicines you and your family take are of an acceptable quality. This quality is assured by a regulatory framework which includes compliance to public standards.
We have launched a <a href="https://www.gov.uk/government/consultations/strategy-for-pharmacopoeial-public-quality-standards-for-biological-medicines">consultation</a> which will look at both how we can best ensure the quality of medicines using standards and how standards can act as enablers for innovation now and in the future.</p>
<h4 id="what-is-a-biological-medicine">What is a biological medicine?</h4>
<p>A biological medicine is a medicine that is derived from a biological (living) source, such as bacteria or viruses, blood, tissues or living cells in culture. Examples are vaccines, insulin, monoclonal antibodies, blood coagulation factors and recombinant DNA proteins.</p>
<h4 id="why-are-biological-medicines-important">Why are biological medicines important?</h4>
<p>Biological medicines such as vaccines have long been among the most important medicines available in preventing killer diseases. Increasingly, newly developed biological medicines will play an important role in global healthcare, opening up many possibilities for the treatment of disease and illness.</p>
<h4 id="what-are-biological-standards">What are biological standards?</h4>
<p>Biological standards are documentary and physical standards used to ensure the quality of biological medicines.</p>
<p>Documentary standards are written descriptions of the quality requirements that medicines have to meet. In the United Kingdom these are published in the <a rel="external" href="http://www.pharmacopoeia.com">British Pharmacopoeia</a>.
Physical standards are materials which are used as bench marks in the scientific tests that demonstrate those quality requirements. In the United Kingdom these are produced by the <a rel="external" href="http://www.nibsc.org">National Institute for Biological Standards and Control (NIBSC)</a>.</p>
<h4 id="who-uses-standards">Who uses standards?</h4>
<p>Standards are used by:</p>
<ul>
<li>companies that manufacture medicines</li>
<li>regulatory (government) authorities with a responsibility to ensure the quality of medicinal products</li>
<li>independent testing laboratories carrying out medical research or other investigations into medicinal quality</li>
</ul>
<h4 id="why-are-standards-needed">Why are standards needed?</h4>
<p>Standards are a key component of ensuring acceptable medicines quality.
Medicines quality refers to the assurance that medicines are developed and manufactured to predefined and reproducible specifications consistent with the clinically tested product.
Standards allow both the public and medical practitioners to have confidence in the quality of the medicines they use.</p>
<h4 id="can-standards-enable-innovation">Can standards enable innovation?</h4>
<p>Yes - standards can help enable manufacturers make use of new and innovative technologies. This forms part of the Agency’s broader support for innovation, which includes MHRA’s <a href="https://www.gov.uk/government/groups/mhra-innovation-office">Innovation Office</a> and Early Access to Medicines scheme.</p>
<h4 id="what-is-the-future-for-biological-standards">What is the future for biological standards?</h4>
<p>We are working closely with stakeholders on how to improve standards for the future.
We have just launched our consultation on documentary standards and would welcome your feedback. The consultation can be found <a href="https://www.gov.uk/government/consultations/strategy-for-pharmacopoeial-public-quality-standards-for-biological-medicines">on our website</a>.</p>
</div>tag:www.gov.uk,2005:AnnouncementPresenter/3479822017-01-03T15:58:20+00:002017-01-03T15:58:20+00:00News story: #FakeMeds in 2017: New Year, Same DangerIn a New Year with new beginnings, the dangers of fake and unlicensed medical products remain the same. We continue our campaign against fake and unlicensed medical products in 2017.<div class="govspeak"><p>As we make our resolutions for 2017, MHRA continues to warn everybody looking to lose weight in the New Year of the dangers of buying diet pills online. Helping us is 25 year old Natalie-Jade, who agreed to share her experience buying diet pills online and reveals why she supports the <a href="https://www.gov.uk/fakemeds">#FakeMeds campaign</a>.</p>
<h3 id="what-motivated-you-to-buy-slimming-pills">1. What motivated you to buy slimming pills?</h3>
<p>I had started to go out with friends and was constantly facing beautiful slim looking women who I kind of began to envy.</p>
<h3 id="what-process-did-you-go-through-to-buy-them">2. What process did you go through to buy them?</h3>
<p>I simply googled the quickest way to lose weight and had easy access to a site that I could purchase from there and then.</p>
<h3 id="did-you-have-an-awareness-that-they-might-not-be-legitimate-did-you-consider-going-to-a-doctor-or-pharmacist">3. Did you have an awareness that they might not be “legitimate”? Did you consider going to a doctor or pharmacist?</h3>
<p>This thought did cross my mind but at that point I had no education on health or what it could potentially do to my body. The before and after pictures did it for me. Going to a doctor or someone professional was embarrassing and to buy over the internet - no one else had to know.</p>
<h3 id="did-you-google-the-ingredients-and-research-what-you-thought-you-were-getting">4. Did you google the ingredients and research what you thought you were getting?</h3>
<p>Not at all. I saw some reviews - whether they were real or not I’ll never know, I just went for it.</p>
<h3 id="what-was-written-on-the-bottle">5 What was written on the bottle?</h3>
<p>The bottle that arrived was a plain white tub. No instructions, no ingredients.</p>
<h3 id="how-did-you-feel-when-you-first-took-them">6. How did you feel when you first took them?</h3>
<p>I felt like I was doing something naughty as I was keeping them secretly hidden from my family and friends.</p>
<h3 id="when-did-you-first-realise-that-they-might-be-affecting-your-health">7. When did you first realise that they might be affecting your health?</h3>
<p>I had stopped eating pretty much altogether. I started to sweat more and was drinking excessive amounts of water.</p>
<h3 id="tell-us-what-happened-when-you-ended-up-in-hospital-and-what-the-aftermath-was">8. Tell us what happened when you ended up in hospital, and what the aftermath was?</h3>
<p>After 8 weeks of taking the pills I’d had enough. I felt like everything was going at 100mph and I needed it to stop. These symptoms calmed slightly but continued for years to follow.
Eventually one day I’d lost all my appetite a migraine came over me and I collapsed.</p>
<p>In hospital I had an ECG (Editor’s note: an electrocardiogram (ECG) is used to test your heart rate) which revealed that my heart rate was abnormally high. After several days and tests later I was told I had Atrial Tachycardia (Editor’s note: AT is a condition that causes your heart to beat at an abnormally high rate because of problems with your heart’s electrical system).</p>
<p>This condition led to anxiety, panic attacks and a general feeling of my heart beating out of my chest which on occasion still happens today. I was told by the cardiology department at the hospital that the pills I took contained Ephedrine, Aspirin and caffeine.</p>
<h3 id="do-you-think-there-needs-to-be-better-awareness-about-the-issue-of-fake-and-unlicensed-medicines-such-as-diet-pills-and-how-to-buy-safely">9. Do you think there needs to be better awareness about the issue of fake and unlicensed medicines such as diet pills, and how to buy safely?</h3>
<p>Yes, 100%. It’s too easy to purchase dodgy diet pills online and it’s so, so dangerous. I thought it would never happen to me, and in the end I was lucky.</p>
<h3 id="what-is-your-message-for-anybody-considering-buying-diet-pills-online">10. What is your message for anybody considering buying diet pills online?</h3>
<p>Don’t do it. There are better, safer and healthier ways. Just ask for advice from someone who is educated and experienced in this field.</p>
<h3 id="looking-back-how-do-you-feel-about-fake-medicines">11. Looking back, how do you feel about fake medicines?</h3>
<p>I am disgusted that people are able to profit through fooling others and putting their lives at risk.</p>
<figure class="image embedded"><div class="img"><img src="https://assets.publishing.service.gov.uk/government/uploads/system/uploads/image_data/file/59811/nat-jade.png" alt="Natalie-Jade"></div></figure>
</div>tag:www.gov.uk,2005:AnnouncementPresenter/3479552016-12-30T15:34:57+00:002016-12-30T15:34:57+00:00News story: Agency highlights 2016Looking back at what the Medicines and Healthcare products Regulatory Agency has achieved over the last year.<div class="govspeak"><p>The Medicines and Healthcare products Regulatory Agency is focussed on protecting and promoting public health through its three centres: Clinical Practice Research Datalink (CPRD), National Institute for Biological Standards and Control (NIBSC) and MHRA.</p>
<p>Here are a few of our 2016 highlights from across the Agency.</p>
<h2 id="supporting-innovation">Supporting innovation</h2>
<p>MHRA supports innovation to help bring improvements in public health and encourages early dialogue with those developing new products. In 2016, our regulatory and scientific advice service arranged a record number of 377 meetings, where our experts provided advice on regulatory requirements, how to achieve quality product development, non-clinical testing and clinical trial designs.</p>
<p>MHRA’s Innovation Office received 122 requests for advice in 2016. A large number of these had to do with innovative products, or interesting new concepts at an early stage of their development.</p>
<p>The number of first in human clinical trials carried out in the UK is also increasing. This is significant as this demonstrates that the UK Life Science sector remains strong and the UK remains a centre of excellence for carrying out initial clinical research activities. In 2016, MHRA assessed 58 first in human trials and 17 trials involving Advanced Therapy Medicinal Products (ATMP).</p>
<h2 id="ensuring-the-safety-of-medical-devices">Ensuring the safety of medical devices</h2>
<p>MHRA plays a key role in the regulation of medical devices by overseeing the essential work of the five UK Notified Bodies; together they are responsible for assessing the majority of devices currently placed on the EU market.</p>
<p>As part of our device surveillance work we issued more than 21 Medical Device Alerts (MDAs) and oversaw the publication of more than 889 Field Safety Notices (FSNs) issued by manufacturers in 2016.</p>
<p>One of our key pieces of work this year was providing updated guidance to help identify which health apps should be regulated as medical devices. We live in an increasingly digital world where healthcare professionals, patients and the public are using software and stand-alone apps to aid diagnosis and monitor health.</p>
<p>Our updated guidance issued in August will help protect people by helping developers decide which apps are medical devices and ensure they are appropriately validated, comply with regulations and are acceptably safe and effective.</p>
<h2 id="fakemeds">#FakeMeds</h2>
<p>This year, MHRA launched a <a href="https://www.gov.uk/fakemeds">public health campaign called #FakeMeds</a>, aimed at educating 18-30 year old adults about how to buy medical products online safely. A substantial proportion of medicines sold online are fake or unlicensed, and we’re raising awareness of how to avoid these products. . Our campaign has been covered by Radio 1’s The Surgery, BBC’s The One Show and ITV’s Coronation Street, The Sun, BBC Online, The Times and several regional papers. After working together on the Radio 1 appearance, the Agency also met up with celebrity doctor Dr Radha, who filmed videos to support our campaign.</p>
<p>You can view our social media activity by searching the hashtag <a rel="external" href="https://twitter.com/hashtag/fakemeds?f=tweets&amp;vertical=default&amp;src=hash">#FakeMeds</a>.</p>
<h2 id="cracking-down-on-illegal-sales-of-medical-products-online">Cracking down on illegal sales of medical products online</h2>
<p>MHRA is always working behind the scenes to stop the illegal sale of medicines and medical devices. Many online sites are selling illegal and potentially dangerous ‘lifestyle’ medicines such as those for erectile dysfunction, and slimming pills.</p>
<p>This year, as part of the global Operation Pangea, we seized more than £13.6m worth of falsified and unlicensed medicines during this week of action in which we particularly targeted people in the UK who try and sell fake medicines online to unsuspecting members of the public.</p>
<h2 id="leading-on-medicines-regulation">Leading on medicines regulation</h2>
<p>MHRA was elected to chair the <a rel="external" href="http://www.icmra.info/">International Coalition of Medicines Regulatory Authorities</a> (ICMRA) for the next two years. This Coalition brings together key medicines regulators from all over the world to work together to jointly address common issues.</p>
<h2 id="providing-data-for-vital-health-research">Providing data for vital health research</h2>
<p>Over the last year CPRD has added more than 4 million patient records to their database of anonymised patient data. This brings their total number of patient lives to more than 21 million. This data will lead to improvements in drug safety, best practice and clinical guidelines.</p>
<h2 id="leading-the-change-on-e-cigarettes">Leading the change on e-cigarettes</h2>
<p>Over the course of 2016 the new regulatory framework for e-cigarettes under the Tobacco Products Directive has been implemented by MHRA as the competent authority. We have now received more than 19,700 submissions.</p>
<h2 id="encouraging-the-reporting-of-suspected-side-effects-to-help-make-medicines-safer">Encouraging the reporting of suspected side effects to help make medicines safer</h2>
<p>As part of our global role in promoting medicines safety, MHRA led an EU-wide social media campaign to promote adverse drug reaction (ADR) reporting and in the UK to increase awareness of the <a rel="external" href="https://yellowcard.mhra.gov.uk/">Yellow Card Scheme</a>.</p>
<p>At the centre of the campaign is an animation created by MHRA showing the story of a patient who has a suspected adverse reaction to a medicine he/she was taking. It shows the medicine being taken, a suspected side effect being experienced, how reports are made by patients or healthcare professionals to the medicines regulator, and how this benefits future patients.</p>
<p>Following a week of action, we raised awareness with our animation being viewed more than 150,000 times and a 17% increase in Yellow Card reports.</p>
<h2 id="innovating-analysis">Innovating analysis</h2>
<p>In October 2016 we launched interactive Drug Analysis Profiles (iDAPs). Each iDAP provides complete data of all spontaneous suspected adverse drug reactions or side effects, which have been reported for a drug substance to MHRA, via the Yellow Card Scheme from either healthcare professionals or members of the public. They also include reports from pharmaceutical companies. iDAPs enable interaction with the data so that the types of reactions that have been reported can be understood, and at a high level understand more about who experienced the side effects.</p>
<p>iDAPs are currently available for 2150 active substances and more than 2300 visitors viewed the interactive profiles in November 2016 on www.yellowcard.mhra.gov.uk/idap.</p>
<p>The new iDAPs allows us to demonstrate greater transparency with regards to the data we collect from Yellow Card reports for licensed medicines. The data is also more clearly displayed and user friendly than the old static pdf files we previously published.</p>
<p>Feedback received from members of the public, healthcare professionals and the pharmaceutical industry has all been positive and users said they appreciate the opportunity to refine the dataset to display Yellow Card data which they are particularly interested in.</p>
<h2 id="supporting-biological-standards-and-control">Supporting biological standards and control</h2>
<p>Each year in the autumn, NIBSC presents proposals for the establishment of new or replacement WHO International Reference Materials that will be developed and manufactured by NIBSC to the World Health Organisation (WHO) Expert Committee on Biological Standardisation (ECBS).</p>
<p>Of the 24 proposals presented this year, over half were for a ‘1st’ International Standard or Panel – including the proposal to make a gene therapy standard.</p>
<p>This year NIBSC and the National Institute of Food and Drug Safety Evaluation (NIFDS) from the Republic of Korea signed a memorandum of understanding (MoU) with the aim of promoting biological standardisation.</p>
<p>This could be achieved through international collaborative studies, the pursuit of areas of mutual benefit, from access to, optimization of processing and transport of material, to building regulatory competence by exchange of scientific experts and joint workshops.</p>
<p>The alliance also helps to enhance the global reach for both sides and highlights the role NIBSC plays in assuring the quality of biological medicines around the world.</p>
<h2 id="saving-the-taxpayer-money">Saving the Taxpayer money</h2>
<p>Earlier this year the Energy Manager at NIBSC was crowned Energy Institute’s ‘Energy Manager of the Year’ at a glittering ceremony in London. This award recognises outstanding individual performance in energy management – from implementing strategies and specifying technology, to engaging employees and other stakeholders.</p>
<p>Single handedly, though with the support of senior managers and colleagues, Jude Hughes established a comprehensive in-house Environmental Management System from scratch at NIBSC, while consistently promoting the development of a ‘green’ culture within the organisation. Jude’s hard work and innovative approaches has resulted in an estimated £1 million saving over the past five years, including a reduction in NIBSC’s electricity and gas usage of 14% and 20% respectively.</p>
<h2 id="continually-improving-our-innovative-yellow-card-app">Continually improving our innovative Yellow Card App</h2>
<p>In an innovative move to mix digital with healthcare services for an improved user experience when reporting suspected problems with medicines, we worked with the Innovative Medicines Initiative WEB-RADR to develop a free Yellow Card app which launched in 2015. The app now has more than 3000 users.
Based upon user feedback the app has been updated to include:</p>
<ul>
<li>Push notification for news items</li>
<li>Simplified login process</li>
<li>Improved scaling for iPhone 6/7 and iPhone 6/7+</li>
<li>Bug fixes and enhancements</li>
</ul>
<p>You can download the app on the <a rel="external" href="https://itunes.apple.com/gb/app/yellow-card-mhra/id990237487?ls=1&amp;mt=8">iTunes app store</a> or <a rel="external" href="https://play.google.com/store/apps/details?id=uk.org.mhra.yellowcard&amp;hl=en_GB">Google Play</a> for android.</p>
<h2 id="working-at-the-agency">Working at the Agency</h2>
<p>For the second year running our annual people survey, independently conducted by ORC International, shows increasing numbers of staff rate us as an engaging place to work.</p>
<p>With a staff of mostly medical and scientific experts, our results compare well with other high-performing civil service organisations (falling within the top 25%).</p>
<p>Our overall staff engagement index in 2016 was measured at 64%, up 1% on the previous year. This continues to build on the 4% increase we achieved on our overall engagement score in 2015.</p>
<p>90% of staff said they found their work interesting, while 62% of respondents, up 2% on the previous year, said they would recommend the Agency as a great place to work.</p>
<h2 id="supporting-access-to-information">Supporting access to information</h2>
<p>This year our Information Services introduced a new discovery search tool, Summon. It allows full-text searching of all e-journal and e-book resources that the Agency has access to, increasing the ability of our customers to find quality scientific information for themselves. Usage statistics of our e-journals was measured in October and showed a significant increase since Summon was activated. User feedback has also been very positive.</p>
<h2 id="addressing-our-customer-needs">Addressing our customer needs</h2>
<p>This year our dedicated customer services team answered more than 16,700 calls from members of the public, healthcare professionals, manufacturers, and many more.</p>
<p>When the team ran a telephone survey more than 81% of people who called the Agency rated their experience at 9/10 or higher. This result was validated by a separate ‘Mystery Shopper’ satisfaction rating of more than 84%.</p>
</div>tag:www.gov.uk,2005:AnnouncementPresenter/3412762016-10-13T13:44:00+01:002016-12-30T09:49:55+00:00News story: MHRA statement on products containing Cannabidiol (CBD)The Medicines and Healthcare products Regulatory Agency has issued an opinion on the regulatory status of products containing CBD <p><em>Updated:</em> Updates statement re: working with companies and trade bodies.</p><div class="govspeak"><p>An MHRA spokesperson said:</p>
<blockquote>
<p>We have come to the opinion that products containing cannabidiol (CBD) used for medical purposes are a medicine. Medicinal products must have a product licence (marketing authorisation) before they can be legally sold, supplied or advertised in the UK, unless exempt. Licensed medicinal products have to meet safety, quality and efficacy standards to protect public health.</p>
<p>If you use CBD and if you have any questions, speak to your GP or other healthcare professional.</p>
<p class="last-child">We have written to UK CBD stockists and manufacturers to inform them of our view. We can provide regulatory guidance to any company who may wish to apply for a licence.</p>
</blockquote>
<h3 id="update-1-november-2016">Update 1 November 2016</h3>
<p>An MHRA spokesperson said:</p>
<blockquote>
<p>While MHRA has given its opinion that products containing cannabidiol (CBD) used for medical purposes are medicines, we have also carefully considered the needs of individuals using CBD products to treat or manage the symptoms of medical conditions.</p>
<p>Our primary concern is patient safety. In order to ensure that products remain available until individuals have the opportunity to discuss their treatment with their doctor, companies now have until 31 December 2016 to voluntarily operate within the law, by withdrawing their existing products from the market, or working with MHRA to satisfy the legal requirements of the Human Medicines Regulations 2012.</p>
<p>We have today written to the manufacturers of CBD to make them aware of the timeline for engagement.</p>
<p class="last-child">It is vital that medicines meet safety, quality and efficacy standards to protect public health.</p>
</blockquote>
<h3 id="update-30-december-2016">Update 30 December 2016</h3>
<p>An MHRA spokesperson said:</p>
<blockquote>
<p>Our primary concern is patient safety and we wish to reiterate that individuals using cannabidiol (CBD) products to treat or manage the symptoms of medical conditions should discuss their treatment with their doctor.</p>
<p class="last-child">MHRA will now work with individual companies and trade bodies in relation to making sure products containing CBD, used for a medical purpose, which can be classified as medicines, satisfy the legal requirements of the Human Medicines Regulations 2012.</p>
</blockquote>
<h3 id="background">Background</h3>
<ol>
<li>This opinion is restricted to products containing cannabidiol (CBD).</li>
<li>MHRA advised manufacturers and suppliers of CBD products that we were reviewing the regulatory status of CBD products prior to this opinion being issued.</li>
<li>The assessment of whether a product is classified as a ‘medicinal product’ is carried out in accordance with the definition of a medicinal product and is not based on whether the product is a risk to consumers. Once a valid application is made the product will be assessed in terms of its safety quality and efficacy in the medical claims made.</li>
<li>Unless exempt, medicines must have a product licence (marketing authorisation) before being placed on the market. Exempt products may be supplied as ‘specials’ by an appropriate prescriber. A ‘special’ can only be supplied in order to meet the special needs of an individual patient and may not be advertised. More information about the ‘specials’ process is available <a href="https://www.gov.uk/government/publications/supply-unlicensed-medicinal-products-specials">on our website</a>.</li>
<li>MHRA have written to 18 companies to advise them of our opinion.</li>
<li>MHRA is responsible for regulating all medicines and medical devices in the UK. All our work is underpinned by robust and fact-based judgments to ensure that the benefits justify any risks. MHRA is a centre of the Medicines and Healthcare products Regulatory Agency which also includes the <a rel="external" href="http://www.nibsc.org/">National Institute for Biological Standards and Control (NIBSC)</a> and the <a rel="external" href="https://www.cprd.com/intro.asp">Clinical Practice Research Datalink (CPRD)</a>. The Agency is an executive agency of the Department of Health. <a rel="external" href="http://www.mhra.gov.uk">www.mhra.gov.uk</a>
</li>
</ol>
</div>tag:www.gov.uk,2005:AnnouncementPresenter/3468702016-12-14T12:16:46+00:002016-12-14T12:16:46+00:00News story: Count down to Christmas with the FakeMeds advent calendarMHRA are revealing a different fact about the issue of fake and unlicensed medical products every day in December leading up to Christmas.<div class="govspeak"><p>MHRA has created the FakeMeds advent calendar this December to tie in with their ongoing campaign to raise awareness of the risks of fake and unlicensed medical products sold online.</p>
<p>A new festive animation is being posted every day on the calendar, which you can view <a rel="external" href="https://a.pgtb.me/FJpCBQ">here</a> and across MHRA’s social media channels (<a rel="external" href="https://twitter.com/MHRAgovuk?ref_src=twsrc%5Egoogle%7Ctwcamp%5Eserp%7Ctwgr%5Eauthor">Twitter</a>, <a rel="external" href="https://www.facebook.com/mhragovuk/">Facebook</a>).</p>
<p>Behind each door are Christmas-themed messages about the kinds of products MHRA seize, warnings about potential health risks, or advice on how to buy safely and report suspected fakes.</p>
<p>The 3 year <a href="https://www.gov.uk/fakemeds">FakeMeds campaign</a> launched in August 2016 with a focus on fake and unlicensed diet pills. MHRA remove thousands of potentially deadly unlicensed slimming medicines from the black market every year.</p>
<p>MHRA has closed down over 5000 websites in 2016 for selling medical products illegally. We continue to target scam sites and criminal gangs.</p>
<p>Future phases of the campaign will focus on other products such as condoms and STI self-test kits, and a new website is planned for early 2017 with detailed consumer information about the issue.</p>
<p>MHRA Senior Policy Manager Lynda Scammell said:</p>
<p>“The FakeMeds advent calendar is a seasonal way of drawing attention to the different aspects of falsified medicines.</p>
<p>“Anything like this that gets the message across in an engaging way is vital to help raise awareness.”</p>
<p>You can view a short video that we shot with celebrity Doctor Radha Modgil to explain the FakeMeds campaign for day seven below.</p>
<p><a rel="external" href="https://www.youtube.com/watch?v=XxZhPmCTLeY&amp;t=9s%20explaining%20the%20campaign">Dr Radha’s FakeMeds Top Tips</a></p>
</div>tag:www.gov.uk,2005:AnnouncementPresenter/3441512016-11-17T13:42:33+00:002016-11-17T13:42:33+00:00News story: MHRA leading European action to reinforce market surveillance of medical devices to protect public healthThe Medicines and Healthcare products Regulatory Agency (MHRA) has officially launched the Joint Action on Market Surveillance of Medical Devices.<div class="govspeak"><p>Medical devices cover a wide range of products – from sticking plasters to hip replacements, from contact lenses to personal oxygen tanks and implanted pacemakers. These devices and others like them, can be found in every household across Europe, once they have been CE marked.</p>
<p>To make sure devices like these are acceptably safe and perform as intended, Competent Authorities need to have a strong programme of market surveillance.</p>
<p>On 19 October 2016, at the 39th meeting of the Competent Authorities for Medical Devices in Bratislava, Slovakia, <abbr title="Medicines and Healthcare products Regulatory Agency">MHRA</abbr> officially launched the Joint Action on Market Surveillance of Medical Devices.</p>
<p>The project aims to reinforce the market surveillance system for medical devices by improving the coordination of activities by all member states of the European Union, and ensuring adequate communications and cooperation. These are crucial for success and effectiveness of the market surveillance in the field of medical devices.</p>
<p>The Joint Action supports the Consumers, Health, Agriculture and Food Executive Agency’s (Chafea) programme of community action in the field of health to deliver against one of its objectives: to contribute to innovative, efficient and sustainable health systems.</p>
<p>Chafea is entrusted by the European Commission to implement the <a rel="external" href="http://ec.europa.eu/health/programme/policy/index_en.htm">health programme</a> and EU Members States involved in the programme – in January 2016.</p>
<p>John Wilkinson, <abbr title="Medicines and Healthcare products Regulatory Agency">MHRA</abbr>’s Director of Medical Devices, said:</p>
<blockquote>
<p class="last-child">We are pleased to be leading this important activity and look forward to working with our colleagues across the EU in delivering improvements to reinforce market surveillance.</p>
</blockquote>
<h2 id="background">Background</h2>
<ol>
<li>
<p>The Joint Action will be implemented through five work packages: <abbr title="Medicines and Healthcare products Regulatory Agency">MHRA</abbr> leads on three (Coordination dissemination and evaluation), while two will be implemented and delivered by EU Member State partners: the Netherlands (manufacturers’ inspection) and Ireland (clinical process and resource development).
More information about the Joint Action can be found on the <a rel="external" href="http://www.camd-europe.eu/">CAMD website</a></p>
</li>
<li>
<p>To report a suspected problem or incident with a medical device please visit the <a rel="external" href="https://yellowcard.mhra.gov.uk/">Yellow Card Scheme</a> website.</p>
</li>
<li>
<p><abbr title="Medicines and Healthcare products Regulatory Agency">MHRA</abbr> is responsible for regulating all medicines and medical devices in the UK. All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks. <abbr title="Medicines and Healthcare products Regulatory Agency">MHRA</abbr> is a centre of the Medicines and Healthcare products Regulatory Agency which also includes the National Institute for Biological Standards and Control (NIBSC) and the Clinical Practice Research Datalink (CPRD). The Agency is an executive agency of the Department of Health. <a href="https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency">www.mhra.gov.uk</a></p>
</li>
</ol>
<div class="contact postal-address" id="contact_2345">
<div class="content">
<h3>Media enquiries</h3>
<div class="vcard contact-inner">
<p class="adr">
<span class="fn">News centre</span><br>
<span class="street-address"><abbr title="Medicines and Healthcare products Regulatory Agency">MHRA</abbr>
<br>
151 Buckingham Palace Road
<br>
Victoria</span><br>
<span class="locality">London</span><br>
<span class="postal-code">SW1W 9SZ</span>
</p>
<div class="email-url-number">
<p class="email">
<span class="type">Email</span>
<a class="email" href="mailto:newscentre@mhra.gov.uk">newscentre@mhra.gov.uk</a>
</p>
<p class="tel">
<span class="type">During office hours:</span>
020 3080 7651 (08:30 - 17:00)
</p>
<p class="tel">
<span class="type">Out of office hours:</span>
07770 446 189 (17:00 - 08:30)
</p>
</div>
<p class="comments">Office hours are Monday to Friday, 8:30am to 5pm. For real-time updates including the latest press releases and news statements, see our Twitter channel at <a href="https://www.twitter.com/mhrapress">https://www.twitter.com/mhrapress</a></p>
</div>
</div>
</div>
</div>tag:www.gov.uk,2005:AnnouncementPresenter/3416592016-10-17T16:58:30+01:002016-10-17T16:58:30+01:00News story: Teva levothyroxine tablets: re-entry to market and introduction of new tablet strengthsFollowing extensive changes to the formulation and manufacture of levothyroxine tablets by Teva, the Commission on Human Medicines (CHM) is now reassured that Teva has demonstrated an acceptable level of efficacy and safety to allow their levothyroxine tablets to re-enter the market. Additional tablet strengths have also been introduced, to improve precision of dosing. <div class="govspeak"><h3 id="background">Background</h3>
<p>In February 2012 the Commission on Human Medicines (CHM) advised the suspension of the marketing authorisation for levothyroxine 100 microgram tablets manufactured by Teva, following reports of reduced efficacy when patients switched to Teva levothyroxine from other levothyroxine products. There were also manufacturing issues.</p>
<h3 id="suspension-now-lifted">Suspension now lifted</h3>
<p>Teva has followed the CHM’s advice in full, including recommendations following a wider CHM review of levothyroxine tablets, published in January 2013. Teva has undertaken an extensive reformulation of the 50 and 100 microgram tablets, along with manufacturing process improvements that provide assurance of product consistency. In February 2016, CHM reviewed information about the reformulated products and advised that they have an acceptable level of efficacy and safety and could now be re-introduced to the market.</p>
<h3 id="new-tablet-strengths-introduced">New tablet strengths introduced</h3>
<p>Teva has also introduced three additional tablet strengths of 12.5, 25 and 75 micrograms, two of which are new to the UK market. The new tablet strengths will assist dose adjustment for individual patients, which is an important component of optimal thyroid hormone replacement therapy, whilst avoiding the need to split individual tablets.</p>
<p>A total of five tablet strengths will be available from week commencing 17 October, 2016: 12.5, 25, 50, 75 and 100 micrograms.</p>
<h3 id="these-products-do-not-contain-lactose">These products do not contain lactose</h3>
<p>They are therefore suitable for patients who have lactose intolerance, as well as the less common but more serious galactose intolerance.</p>
<h3 id="advice-for-healthcare-professionals">Advice for healthcare professionals</h3>
<ul>
<li>
<p>Clinical studies conducted in volunteers have confirmed that the reformulated Teva levothyroxine tablets produce levels of thyroid hormone in the bloodstream that are equivalent to those produced by the brand leader (UK reference) product.</p>
</li>
<li>
<p>The formulation and manufacturing process improvements provide assurance that equivalent systemic availability will apply to future batches of product, and that this will be maintained over the duration of the shelf-life. Assurance of consistency in performance is therefore provided.</p>
</li>
<li>
<p>Lactose, converted in the body to galactose, has been removed from the formulation. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption can now take this medicine.</p>
</li>
<li>
<p>Patients should continue to be monitored at intervals for clinical signs and symptoms of adequate thyroid hormone replacement, together with measurement of TSH levels. Patients can display differences in thyroid hormone response, and can require adjustments in dose, for reasons that are unrelated to pharmaceutical properties of the product.</p>
</li>
</ul>
<h3 id="further-information">Further information</h3>
<p>For more information on the assessment of the re-formulated products and the additional strengths, please refer to the Public Assessment Reports (PARs), which can be accessed here:</p>
<p><a rel="external" href="http://www.mhra.gov.uk/home/groups/par/documents/websiteresources/con738144.pdf">Levothyroxine 50 microgram Tablets and Levothyroxine 100 microgram Tablets (PL 00289/0038-39)</a></p>
<p><a rel="external" href="http://www.mhra.gov.uk/home/groups/par/documents/websiteresources/con738143.pdf">Levothyroxine 12.5 microgram Tablets, Levothyroxine 25 microgram Tablets and Levothyroxine 75 microgram Tablets (PL 00289/1971-73)</a></p>
</div>tag:www.gov.uk,2005:AnnouncementPresenter/3388452016-09-09T11:51:34+01:002016-09-09T11:51:34+01:00News story: Statement on StatinsStatement from Medicines and Healthcare products Regulatory Agency on the risks and benefits of statins. <div class="govspeak"><p>Dr June Raine, Director of MHRA’s Vigilance and Risk Management of Medicines (VRMM) Division said:</p>
<blockquote>
<p>The benefits of statins are well established and are considered to outweigh the risk of side-effects in the majority of patients. The efficacy and safety of statins has been studied in a number of large trials which show they can lower the level of cholesterol in the blood and reduce cardiovascular disease and can save lives. Trials have also shown that medically significant side effects are rare.</p>
<p>Medicine safety and effectiveness is of paramount importance and under constant review. Our priority is to ensure that the benefits of medication outweigh the risks. Any new significant information on the efficacy or safety of statins will be carefully reviewed and action will be taken if required.</p>
<p>Information on potential side effects can be accessed through the patient information leaflets and any suspected side effects reported to us through our warning system, the Yellow Card Scheme, are publicly available on <a href="https://www.gov.uk/guidance/the-yellow-card-scheme-guidance-for-healthcare-professionals">our website</a>.</p>
<p class="last-child">If you have any questions about your medicine, please speak to your GP or healthcare professional.</p>
</blockquote>
</div>tag:www.gov.uk,2005:AnnouncementPresenter/3372452016-08-19T10:39:00+01:002016-08-19T10:39:00+01:00News story: GCP, GLP and Clinical Laboratories Symposia19 August 2016<div class="govspeak"><h2 id="about-the-conference">About the conference</h2>
<p>The <abbr title="Medicines and Healthcare products Regulatory Agency">MHRA</abbr> GCP and GLP/GCP Laboratory symposiums will provide a unique platform for cross-collaboration and discussion between regulators and members of the commercial and non-commercial research community on the latest hot topics and regulatory updates related to the Good Clinical Practice and Good Laboratory Practice.</p>
<div class="call-to-action">
<p>If you have not yet booked your place, <a rel="external" href="http://www.mhra-gcpglp.glasgows.co.uk">book now to avoid disappointment</a> as spaces are filling up fast.</p>
</div>
<h3 id="who-should-attend">Who should attend</h3>
<p>These are must attend events to all individuals from the pharmaceutical industry sponsoring and managing clinical trial activities in both the commercial and non-commercial setting and those involved in the management and conduct of Good Laboratory Practice studies.</p>
<p>GCP symposium will be of interest to clinical trial pharmacists and technicians, staff collecting, reviewing and reporting clinical trial data as well as planning, conducting, reporting, publishing clinical trials.</p>
<h3 id="why-should-i-attend">Why should I attend?</h3>
<p>You should attend to:</p>
<ul>
<li>keep up to date with GCP requirements and <abbr title="Medicines and Healthcare products Regulatory Agency">MHRA</abbr> expectations regarding conduct of clinical trials.</li>
<li>keep up to date with GCP and GLP requirements and <abbr title="Medicines and Healthcare products Regulatory Agency">MHRA</abbr> expectations regarding conduct of analysis of samples from clinical trials.</li>
<li>keep up to date with GLP requirements and international expectations regarding conduct of GLP studies.</li>
<li>recognise the types of compliance issues that test facilities have to deal with on a day to day basis and understand how the regulators address these issues on a case by case basis to maintain acceptable levels of compliance and encouraging innovative and flexible thinking.</li>
<li>take advantage of the opportunity to share concerns and best practice with others.</li>
<li>gather information which will help you in assessing your own quality systems and potentially identify smart solutions to issues regularly encountered by inspectors and research professionals.</li>
<li>discover what your peers are doing through managed interactive sessions.</li>
<li>meet the inspectorate teams and have the opportunity to ask questions on specific aspects affecting your organisation.</li>
<li>understand how the GLPMA (Good Laboratory Practice Monitoring Authority) and GCP inspectors address complex compliance issues and learn more about the inspectorate’s approach to risk based inspection.</li>
<li>discuss current hot topics and be aware of areas of compliance that monitoring authorities are likely to focus on during routine inspections.</li>
</ul>
<h2 id="details">Details</h2>
<h3 id="dates-and-location">Dates and location</h3>
<p>Tuesday 20th – Wednesday 21st September 2016 – GCP Symposium
Thursday 22nd September 2016 – GLP and GCP Laboratory Symposium</p>
<div class="address"><div class="adr org fn"><p>
Macdonald Burlington Hotel, Birmingham
<br>Burlington Arcade
<br>126 New Street
<br>Birmingham
<br>B2 4JQ
<br>United Kingdom
<br>
</p></div></div>
<p>Tel: (+44) 0121 643 9191</p>
<h3 id="cost">Cost</h3>
<table>
<tbody>
<tr>
<td>GCP symposium</td>
<td>Standard rate</td>
<td>Non-commercial: £295 + VAT</td>
<td>Industry: £575 + VAT</td>
</tr>
<tr>
<td>GLP and GCP Laboratory symposium</td>
<td>Standard rate</td>
<td>Non-commercial: £295 + VAT</td>
<td>Industry: £575 + VAT</td>
</tr>
<tr>
<td>GCP and GLP/GCP Laboratory symposium</td>
<td>Standard rate</td>
<td>Non-commercial: £525 + VAT</td>
<td>Industry: £875 + VAT</td>
</tr>
</tbody>
</table>
<p>Please register your place <a rel="external" href="http://www.mhra-gcpglp.glasgows.co.uk">via the event website</a>. If you have not yet booked your place, book now to avoid disappointment as spaces are filling up fast. Attendees will be eligible for CPD points</p>
<h2 id="social">Social</h2>
<p>Join the <a rel="external" href="https://twitter.com/MHRAgovuk">Twitter conversation</a> at <a rel="external" href="https://twitter.com/search?q=%23MHRAGCP&amp;src=typd">#MHRAGCP</a> and <a rel="external" href="https://twitter.com/search?q=%23MHRALabs&amp;src=typd">#MHRALabs</a> and connect with us on <a rel="external" href="http://www.linkedin.com/company/mhra">LinkedIn</a></p>
</div>tag:www.gov.uk,2005:AnnouncementPresenter/3357812016-08-03T00:04:00+01:002016-08-03T00:04:00+01:00News story: MHRA urges people to be cautious when buying sports supplementsA review into the sports supplement industry ahead of the Rio 2016 Olympic games shows the sport supplement industry is improving.<div class="govspeak">
<p>The MHRA carried out a new review of sports supplements to coincide with the 2016 Summer Olympics, which shows a reduction of sports supplements being sold as unauthorised medicines by almost 50% compared to a similar study carried out in 2012.</p>
<p>The review is part of the MHRA’s ongoing commitment to protect people from potentially dangerous products. This is an encouraging sign and points to the sports supplement industry taking account of MHRA concerns regarding the sale of products regulated as medicines.</p>
<p>The MHRA’s Medicines Borderline section invited 33 UK based companies to carry out a review of their product ranges and subsequently took action to remove unauthorised medicinal products from the market. These contained a number of ingredients which cause a significant physiological effect and would be regarded to be medical products.</p>
<p><a rel="external" href="https://www.youtube.com/watch?v=Dm8kthb1Prg">Dr Chris Jones Interview</a></p>
<p>The review found that 69 unauthorised medicines were being sold as sports supplements and 16 companies were found to be selling one or more unauthorised medicines.</p>
<p>Prior to the 2012 Olympic games, the MHRA reviewed 36 sports supplement websites, with 24 found to be selling one or more illegal products. This resulted in 129 illegally branded products being pulled from sale in the UK.</p>
<p>The MHRA will always investigate instances of the sale and supply of unauthorised medicinal products, including those that may be present in sports supplements.</p>
</div>tag:www.gov.uk,2005:AnnouncementPresenter/3356372016-08-01T16:25:02+01:002016-08-01T16:25:02+01:00News story: Clinical Trials Regulations – have your sayThe Medicines and Healthcare products Regulatory Agency invites interested parties to provide feedback on Clinical Trial Regulation guidance documents.<div class="govspeak"><p>Following the EU referendum, MHRA continues to play a full, active role in European regulatory procedures. The UK is assessing the potential impact on our regulatory framework of the decision to leave the EU. At present, we continue with our programme for implementing the Clinical Trials Regulations and we remain an EU Member State with the rights and responsibilities this entails.</p>
<p>This consultation seeks the views of stakeholders – and other interested parties – on the document regarding “Risk proportionate approaches in clinical trials”. The main objective of these recommendations is to provide further information on how a risk proportionate approach can be implemented in clinical trials and also highlights the areas identified in the clinical trials Regulation which support and facilitate such adaptations.</p>
<p>There are currently four consultations on guidance documents that have been developed in preparation for the implementation of the Clinical Trial Regulation (EU) No 536/2014:</p>
<ul>
<li>“Risk proportionate approaches in clinical trials” - providing further information on how a risk proportionate approach can be implemented in clinical trials and highlighting areas within the clinical trials Regulation which support such adaptations;</li>
<li>Revision of the “Definition of Investigational Medicinal Products (IMPs) and use of Auxiliary Medicinal Products (AMPs)” (previously called “Guidance on Investigational Medicinal Products (IMPS) and Non-Investigational Medicinal Products (NIMPs));</li>
<li>Revision of “Ethical Considerations for Clinical Trials on Medicinal products conducted with Minors”; and</li>
<li>“Summary of Clinical Trial Results for Laypersons”.</li>
</ul>
<p>These are currently out for public consultation from 1 June 2016 to 31 August 2016.</p>
<p>The documents are available on the <a rel="external" href="http://ec.europa.eu/health/human-use/clinical-trials/developments/index_en.htm">European Commission website</a>.</p>
<p>Your comments are welcomed by e-mail to the relevant address for each document:</p>
<ul>
<li>“Risk proportionate approaches” <a href="mailto:SANTE-B4-GL-risk-proportionate-approach@ec.europa.eu">SANTE-B4-GL-risk-proportionate-approach@ec.europa.eu</a>
</li>
<li>“Definition of Investigational Medicinal Products (IMPs) and use of Auxiliary Medicinal Products (AMPs)” <a href="mailto:SANTE-B4-GL-IMP-AMP@ec.europa.eu">SANTE-B4-GL-IMP-AMP@ec.europa.eu</a>
</li>
<li>“Ethical Considerations for Clinical Trials on Medicinal products conducted with Minors” <a href="mailto:SANTE-B4-GL-Ethics-Minors@ec.europa.eu">SANTE-B4-GL-Ethics-Minors@ec.europa.eu</a>
</li>
<li>“Summary of Clinical Trial Results for Laypersons” <a href="mailto:SANTE-B4-GL-results-laypersons@ec.europa.eu">SANTE-B4-GL-results-laypersons@ec.europa.eu</a>
</li>
</ul>
</div>tag:www.gov.uk,2005:AnnouncementPresenter/3343142016-07-21T11:25:00+01:002016-07-21T11:25:00+01:00News story: MHRA GxP Data Integrity Definitions and Guidance for IndustryMHRA has produced draft GxP data integrity guidance for industry and we welcome your comments<div class="govspeak"><p>This <span id="attachment_1644434" class="attachment-inline">
<a href="/government/uploads/system/uploads/attachment_data/file/538871/MHRA_GxP_data_integrity_consultation.pdf">consultation document</a>
(<span class="type"><abbr title="Portable Document Format">PDF</abbr></span>, <span class="file-size">207KB</span>, <span class="page-length">14 pages</span>)
</span>
provides guidance on the data integrity expectations that should be considered by organisations involved in any aspect of the pharmaceutical lifecycle or GLP studies regulated by MHRA.</p>
<p>The guidance is intended to be a useful resource on the core elements of a compliant data governance system across all GxP sectors (good laboratory practice, good clinical practice, good manufacturing practice, good distribution practice and good pharmacovigilance practice).</p>
<p>It addresses fundamental failures identified by MHRA and international regulatory partners during GLP, GCP, GMP and GDP inspections; many of which have resulted in regulatory action.</p>
<p>The document should be read in conjunction with the applicable regulations and the general guidance specific to each GxP.</p>
<p>We welcome your comments via the <span id="attachment_1644433" class="attachment-inline">
<a href="/government/uploads/system/uploads/attachment_data/file/538879/Comment_sheet.doc">comment sheet</a>
(<span class="type">MS Word Document</span>, <span class="file-size">224KB</span>)
</span>
which can be emailed to <a href="mailto:inspectorate@mhra.gsi.gov.uk">inspectorate@mhra.gsi.gov.uk</a></p>
<p>Deadline for comments: 31 October 2016</p>
</div>tag:www.gov.uk,2005:AnnouncementPresenter/3337302016-07-11T15:54:41+01:002016-07-11T15:54:41+01:00News story: Volunteers wanted to help determine the future of pharmacovigilanceWeb-RADR: Recognising Adverse Drug Reactions is running a survey for healthcare providers, patients, and consumers of medicines to help develop the next generation of online side-effect reporting software.<div class="govspeak"><p>Led by MHRA, the European project <a rel="external" href="http://web-radr.eu/">Web-RADR</a> is a ground-breaking three-year project to digitally revolutionise the way adverse drug reactions are reported and monitored.
The survey asks healthcare providers and patients for their opinions about apps to report adverse drug reactions as well as to track and receive news and alerts about particular medicines.</p>
<p>Results of the survey will be used to:</p>
<ul>
<li>further improve MHRA’s Yellow Card app (available on <a rel="external" href="https://itunes.apple.com/app/apple-store/id990237487?pt=117756671&amp;ct=3BSurvey-07-2016&amp;mt=8">iOS</a> and <a rel="external" href="https://play.google.com/store/apps/details?id=uk.org.mhra.yellowcard&amp;referrer=utm_source%3D3BSurvey-07-2016%26utm_medium%3Dcpc%26anid%3Dadmob">Android</a>
</li>
<li>increase general knowledge about reporting adverse drug reactions and receiving safety information about medicines.</li>
</ul>
<p>Completing the survey is anonymous and will take approximately 15-20 minutes. Your contribution to the survey will help improve pharmacovigilance across the UK and Europe.
As a token of appreciation, participants can enter a prize draw to win a €50 coupon upon completion.</p>
<p><a rel="external" href="https://www.unipark.de/uc/HCP/EN/">Survey for healthcare providers</a></p>
<p><a rel="external" href="https://www.unipark.de/uc/PT/EN/">Survey for patients or consumers of medicines</a></p>
</div>tag:www.gov.uk,2005:AnnouncementPresenter/3315432016-06-20T11:28:04+01:002016-06-20T11:28:04+01:00News story: Interrogating research to protect public healthPart of the work of the medicines and medical device regulator involves looking at existing research to help reach conclusions about potential and emerging issues with devices.<div class="govspeak"><p>Monitoring new and emerging safety issues with medicines and medical devices is a major part of the work the Medicines and Healthcare products Regulatory Agency (MHRA) undertakes to protect public health.</p>
<p>In addition to monitoring reports from our <a rel="external" href="https://yellowcard.mhra.gov.uk/">Yellow Card Scheme</a>, teams of experts across the agency review published information to assist in understanding areas where concerns have been raised regarding medical devices. In this instance, concerns were raised about the safety of implanting polypropylene into patients. Our review resulted in the publication of a paper in an internationally respected, peer reviewed journal.</p>
<p>This work has never before been undertaken in such a thorough and systematic way and has served to gather all of the relevant data together in one place for the first time.</p>
<p>The <a rel="external" href="http://link.springer.com/journal/192">International Urogynecology Journal</a> has recently published a paper by Michelle Kelly, Katherine Macdougall, Oluwafisayo Olabisi and Neil McGuire of the MHRA device division titled <a rel="external" href="http://link.springer.com/article/10.1007%2Fs00192-016-3029-1">In vivo response to polypropylene following implantation in animal models: a review of biocompatibility</a>.</p>
<p>Polypropylene is a material commonly used to treat pelvic floor conditions such as pelvic organ prolapse (POP) and stress urinary incontinence (SUI). It is the material used in the majority of mesh medical devices.</p>
<p>All relevant abstracts from original articles investigating the host response of mesh ‘in vivo’ were reviewed. Papers were obtained and categorised into various mesh material types and the results from the studies were carefully interrogated and evaluated.</p>
<p>Ultimately, the review of the evidence shows that polypropylene evokes a less inflammatory response compared to other materials which are or can be used in mesh devices in humans. It was also indicated that a lightweight, large pore mesh provides the most satisfactory outcomes.</p>
<p>While some promising outcomes have been observed with the use of biologically derived and fully reabsorbable meshes, both these types of material currently lack the mechanical strength required for long-lasting repair.</p>
<p>What was seen, and continues to be seen through research evaluated as part of this paper, is that the greater proportion of the clinical community agree the use of these devices in the UK is a valuable treatment option for the distressing conditions of stress urinary incontinence and pelvic organ prolapse. However it is clear longer term studies need to be completed in patients. As with all implanted medical devices, to date, it is recognised they all produce some degree of inflammatory reaction so the search for even better alternatives must continue, even though this is in part, how they produce their strengthening action.</p>
<p>We are committed to helping to address the serious concerns that have been raised by some patients and continuously assess findings of studies undertaken by the clinical community over many years, as well as considering feedback from all sources. MHRA sympathises greatly with women who have suffered complications after surgery.</p>
</div>